Leveraging Interactive Text Messaging to Monitor and Support Maternal Health in Kenya
Phase: NA
Conditions: Neonatal Death, Perinatal Death, Depression
Sponsor: University of Washington

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TITLE: Leveraging interactive SMS messaging to monitor and support maternal health in Kenya (AI-NEO) 
NCT number: NCT05369806 
PI name: Ronen 
Document date: 12 Nov 2021 
IRB approval date: 15 Nov 2021 
 
 

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APPLICATION IRB Protocol 
 
 
 
The Human Subjects Division (HSD) strives to ensure that people with disabilities have access to all services and content. If you 
experience any accessibility-related issues with this form or any aspect of the application process, email 
hsdinfo@uw.edu for assistance. 
 
INSTRUCTIONS 
• 
This form is only for studies that will be reviewed by the UW IRB. Before completing this form, check HSD’s website to 
confirm that this should not be reviewed by an external (non-UW) IRB. 
• 
If you are requesting a determination about whether the planned activity is human subjects research or qualifies for exempt 
status, you may skip all questions except those marked with a          . For example 1.1 must be answered. 
• 
Answer all questions. If a question is not applicable to the research or if you believe you have already answered a question 
elsewhere in the application, state “NA” (and if applicable, refer to the question where you provided the information). If you 
do not answer a question, the IRB does not know whether the question was overlooked or whether it is not applicable. This 
may result in unnecessary “back and forth” for clarification. Use non-technical language as much as possible.  
• 
To check a box, place an “X” in the box. To fill in a text box, make sure your cursor is within the gray text box bar before 
typing or pasting text. 
• 
For collaborative or multi-site research, describe only the UW activities unless you are requesting that the UW IRB provide 
the review and oversight for non-UW collaborators or co-investigators as well.  
• 
You may reference other documents (such as a grant application) if they provide the requested information in non-technical 
language. Be sure to provide the document name, page(s), and specific sections, and upload it to Zipline. Also, describe any 
changes that may have occurred since the document was written (for example, changes that you’ve made during or after the 
grant review process). In some cases, you may need to provide additional details in the answer space as well as referencing a 
document.  
• 
NOTE: Do not convert this Word document to PDF. The ability to use “tracked changes” is required in order to modify your 
study and respond to screening requests.  
 
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: 
Leveraging interactive SMS messaging to monitor and support maternal health in Kenya 

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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.   
 
X No 
 
 
 
Yes 
à If yes, briefly describe the consultation: approximate date, with whom, and method (e.g., by email, 
phone call, in-person meeting). 
 
 
 
 
      
1.3 Similar and/or related studies. Are there any related IRB applications that provide context for the proposed 
activities? 
Examples of studies for which there is likely to be a related IRB application: Using samples or data collected by another study; 
recruiting subjects from a registry established by a colleague’s research activity; conducting Phase 2 of a multi-part project, or 
conducting a continuation of another study; serving as the data coordinating center for a multi-site study that includes a UW 
site. 
 
Providing this information (if relevant) may significantly improve the efficiency and consistency of the IRB’s review. 
 
 
No 
 
 
X 
Yes 
à 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. 
 
 
 
STUDY00006395 – similar procedures; Aim 3 of this application will be nested within 6395 
 
STUDY00009531 – formative secondary data analysis in 9531 led to development of 
computational models that will be used in this application 

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1.4 Externally-imposed urgency or time deadlines. Are there any externally-imposed deadlines or urgency that affect 
the proposed activity? 
HSD recognizes that everyone would like their IRB applications to be reviewed as quickly as possible. To ensure fairness, it is 
HSD policy to review applications in the order in which they are received. However, HSD will assign a higher priority to 
research with externally-imposed urgency that is beyond the control of the researcher. Researchers are encouraged to 
communicate as soon as possible with their HSD staff contact person when there is an urgent situation (in other words, before 
submitting the IRB application). Examples: a researcher plans to test an experimental vaccine that has just been developed for 
a newly emerging epidemic; a researcher has an unexpected opportunity to collect data from students when the end of the 
school year is only four weeks away.  
 
HSD may ask for documentation of the externally-imposed urgency. A higher priority should not be requested to compensate 
for a researcher’s failure to prepare an IRB application in a timely manner. Note that IRB review requires a certain minimum 
amount of time; without sufficient time, the IRB may not be able to review and approve an application by a deadline.  
 
X 
No 
 
 
 
Yes 
à If yes, briefly describe the urgency or deadline as well as the reason for it. 
 
 
 
      
1.5 Objectives Using lay language, describe the purpose, specific aims, or objectives that will be met by this specific 
project. If hypotheses are being tested, describe them. You will be asked to describe the specific procedures in a 
later section. 
 
If this application involves the use of a HUD “humanitarian” device: describe whether the use is for “on-label” 
clinical patient care, “off-label” clinical patient care, and/or research (collecting safety and/or effectiveness data). 
 
Our overarching aim is to implement a natural language processing (NLP) model into the previously developed 
Mobile WACh SMS platform and test its acceptability and impact on healthcare workers response time. 
 
Aim 1: Validate performance of an NLP model trained to detect urgent client SMS. 
Ten nurses from Mobile WACh studies will be presented with client messages from previous Mobile WACh 
studies, annotated with urgency predictions from the top 3 best performing NLP models. Each nurse will be asked 
to report their agreement with each prediction. The model with the highest sensitivity and specificity compared 
with the nurse “gold standard” determination will be selected for implementation in the Mobile WACh system. 
 
Aim 2: Using a human-centered design approach, adapt the Mobile WACh system nurse interface to 
dynamically display urgent incoming messages. 
Interactive focus groups will be conducted with 6-10 nurses from Mobile WACh studies and MOH facilities to 
collectively design a user interface that integrates real-time urgency classification of incoming messages and 
highlights messages classified as urgent. 
 
Aim 3: Pilot the adapted Mobile WACh interface (AI-NEO) that identifies urgent client SMS and evaluate 
its acceptability and effect on nurse response time. 
We will enroll 80 pregnant women to receive the AI-NEO SMS intervention. Women will be enrolled at 28-36 
weeks gestation and will receive automated SMS regarding neonatal health from enrollment until 6 weeks 
postpartum, and will have the ability to interactively message with study nurses. Participant messages will be 
automatically categorized by urgency. We will evaluate intervention acceptability and recommended 
improvements among clients and nurses using quantitative and qualitative data collection at study exit (quantitiave 
questionnaires with all client participants and qualitative interviews with 4 nurses). We will compare nurse 
response time to urgent and non-urgent participant messages with the ongoing Mobile WACh NEO trial, in which 
a non-adapted Mobile WACh system is used. 
 

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

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11. Other. Explain: 
 
 
 
 
 
 
 
      
1.8 Background, experience, and preliminary work. Answer this question only if 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. 
 
Despite recent reductions in under-five mortality, neonatal mortality remains high. 
The risk of a newborn dying depends significantly on where in the world they are born. Neonatal mortality 
rates (NMRs) vary substantially between countries from 1 to 44 per 1000 live births; almost 98% of neonatal 
deaths occur in low to middle income countries.1 While the global NMR has fallen in recent decades, it still 
lags behind the impressive gains made for children 1 month to 5 years old. Between 1990 and 2016, under-5 
mortality dropped by 62%, compared to 49% in neonates.2 As a result, newborn deaths now account for a 
growing proportion of under-5 mortality. Moreover, many neonatal deaths occur at home and are therefore 
underreported. In Kenya, the NMR is 22.6 per 1000 live births,3 ranking among the countries with the highest 
number of neonatal deaths (~40,000 per year).2 Siaya County in Western Kenya has a NMR of 27.3 per 1000 
live births.4 National implementation of a free maternal health care policy and the resulting rise in facility 
deliveries have not had a significant impact on neonatal mortality.5 Achieving Sustainable Development Goal 
3 of £12 neonatal deaths per 1000 live births by 2030 will require increased access to effective, evidence-
based interventions that specifically address neonatal survival.6 Moreover, improving health during the 
critical neonatal period has the potential to not only support survival but also improve long-term 
developmental outcomes.7 
 
Mobile health (mHealth) interventions can provide on-demand information and support families to 
improve maternal child health.  
mHealth tools, which utilize mobile phones and other wireless technologies to support health, provide an 
attractive strategy to augment community-based care and connect households to CHV support more 
efficiently and frequently. More households in low-income countries own a mobile phone than have access 
to electricity or adequate sanitation.8 According to the Communications Authority of Kenya, there are now 46 
million phone subscriptions in Kenya, for a national population of 43 million.9 A World Bank report found 
that Kenyans living at the so-called economic “bottom of the pyramid” reported health information and 
communication was the service they most wanted to receive through their mobile phones.10 
 

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Our collaborative team has developed an open-source human-computer hybrid SMS platform, Mobile WACh 
(Mobile Solutions for Women’s and Children’s Health).11 Mobile WACh sends pre-composed messages to 
clients at scheduled times. Clients may send messages at any time; a live HCW answers incoming messages, 
leading to personalized dialogue. The internet-based HCW interface contains a dashboard designed to 
facilitate HCW management of tasks such as message response, patient tracking, and message translation 
into English. The system back-end collects SMS metadata such as time stamps and delivery status, as well as 
data on seminal events such as childbirth. To date, Mobile WACh has been implemented in 7 studies 
(including 4 randomized controlled trials, RCTs) targeting a range of reproductive, maternal, neonatal and 
child health outcomes. Scheduled intervention messages were developed for each study based on formative 
research with the target population,12–14 and behavioral theory selected based on the target outcome (Social 
Cognitive Theory,15,16 Theory of Planned Behavior,17,18 or Information-Motivation-Behavior Change 
Theory19,20). All studies also allowed unstructured, personalized dialogue between clients and HCWs. This 
suite of studies provides well-developed software and rich data (400,000 SMS) for the proposed project 
(Table 1). 
 
Table 1. Mobile WACh study summary 
Study 
Primary outcome 
N clients 
N SMS 
Follow-up 
period 
Automated 
system 
Personalized 
nurse 
Client 
Mobile WACh XY 
RCT17 
Family planning 
130  
6,852  
(144 unique) 
          3,356  
       3,577  Preg - 6mo 
Mobile WACh Neo 
pilot (NEO Pilot)20 
Neonatal health 
799  
26,021 
(62 unique)  
        13,535  
     19,952  Preg - 3mo 
Mobile WACh X RCT16 HIV treatment 
adherence 
276  
39,993  
(1149 unique)           6,361  
     10,122  Preg - 2yr 
Mobile WACh Neo 
RCT (NEO RCT) 
Neonatal health, 
Maternal depression 
2,500  
 NA  
 NA  
 NA  
Preg - 2mo 
  
 
Automation may enable mHealth interventions to maximize efficiency and adaptability.  
The public health impact of mHealth interventions in resource-
limited settings rests on their ability to achieve the following: 
(1) reach the people who most need support, (2) deliver 
efficacious treatment, and (3) reduce the burden on 
overstretched HCWs. Furthermore, there is increasing 
recognition that an mHealth intervention may be most 
efficacious if it is delivered at the right time and adapts based 
on the context and response of individual clients.21 This idea is 
articulated in the paradigm of just-in-time adaptive 
intervention (JITAI) design.22,23 Many mHealth interventions 
are inherently adaptive – particularly those that include 
dynamic interaction with a human. The JITAI paradigm 
involves formalization of when and how the intervention should be adapted, by defining decision points, 
decision rules, and intervention options (Fig. 1). Implementation of this process can only feasibly be 
accomplished with automatic, real-time processing of client data (in the case of SMS interventions, 
unstructured natural language).22,24 Table 2 summarizes the ways that automation can maximize mHealth 
intervention impact.  
 
 
 
Natural language processing (NLP) enables computational analysis of unstructured language. 
Table 2. Applications of automation in mHealth 
mHealth function 
Application of automation 
Figure. 1. Schematic of just-in-time 
adaptive intervention design  
Adapted from Nahum-Shani et al.27  

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NLP refers to methods that transform and represent 
natural language for computation.25,26 Used in ubiquitous 
tools such as internet searching and email spam filtering, 
NLP is receiving growing attention in biomedical fields as a 
way to harness large quantities of rich, free text data, 
which are prohibitively resource-intensive to manually 
summarize.27–29 Essentially, NLP breaks a piece of text (a 
corpus) into its constituent tokens (typically words) and 
represents each token numerically. Many approaches have 
been developed for numerical representation. They range from representing each word type as an arbitrary 
integer and summarizing the corpus by word frequencies, to representing each word as a multidimensional 
vector of features.30 Features can be assigned based on expert linguistic knowledge, for example a 
categorical variable indicating parts of speech or root word.25,26 Recently, machine learning algorithms have 
been developed for contextual word embedding – feature definition based on a word’s distribution in other 
corpora, on the grounds that words found in similar contexts have similar meanings.31–33 These algorithms 
have been shown to have excellent performance as predictors in a variety of classification tasks,30 but the 
features they identify are generally not interpretable by humans.  
 
Machine learning (ML) methods can be used to predict clinical outcomes 
based on natural language.  
ML refers to computer algorithms that derive parameters of 
mathematical models by iteratively learning from observed data.34,35 ML 
can be supervised, meaning labeled data with linked predictor and 
outcome values are available to train the model; or unsupervised, 
meaning data are unlabeled and the algorithm clusters similar data 
together without considering outcome. ML methods can be used in 
analysis of unstructured natural language such as SMS messages in 
several ways. As described above, unsupervised ML models known as 
neural networks can be used to generate feature vectors from text.30 
Additionally, feature vectors generated by (ML or non-ML) NLP can in 
turn be used as predictors in supervised ML tasks such as classifying 
whether text indicates a particular health outcome (Fig. 2).  
 
REACH people in need 
Identify clients when they are 
in need of support 
Deliver EFFECTIVE 
intervention 
Standardize intervention 
delivery 
Adapt intervention to client 
status & response 
REDUCE BURDEN on HCW 
Reduce manual message 
review & triage 
Prompt, guide or compose 
HCW messages 
 
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. 
 
 
We have developed NLP models with promising performance for detection of urgent client messages. 
Figure. 2. Use of NLP & ML for SMS 
analysis     
 
t=time 

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Using 1497 messages sent by the 30 most active participants in the Mobile WACh NEO pilot study, we 
developed NLP models using message metadata, word frequencies and contextual word embeddings to 
detect clinical urgency of messages. Fig. 3 displays precision-recall curves summarizing performance of 6 
representative models using a variety of linguistic features and modeling approaches. To evaluate potential 
clinical usefulness of models, we identified two potential model applications and associated evaluation 
criteria. A “triage” model rules out messages by identifying with very high recall (sensitivity) the messages of 
interest (i.e. urgent messages) for healthcare 
workers to focus their review on, while 
significantly reducing the number of messages 
reviewed. A “prioritize” model identifies 
messages of interest with very high precision 
(positive predictive value), allowing healthcare 
workers to read those messages first, while still 
reading the remaining messages later. Each 
ideal model occupies a region on the precision-
recall plot; a model whose precision-recall curve 
falls in one of the two regions would be a 
candidate model for pilot testing. To date, we 
have developed one model close to the “triage” 
region. We are continuing to optimize model 
performance and are optimistic we can achieve 
further performance gains. 
 
The ongoing Mobile WACh NEO RCT presents an opportunity to evaluate feasibility and performance of 
NLP models in practice  
While model performance relative to a known label can be summarized using variables such as precision and 
recall, the utility of NLP for improving efficiency of nurse workflow must be determined empirically. We 
therefore propose to conduct a pilot study in which we compare nurse workflows when using the 
conventional Mobile WACh platform vs. workflows when using an NLP-enabled Mobile WACh platform. An 
ongoing RCT, Mobile WACh NEO, is evaluating use of the Mobile WACh platform to support neonatal health 
in Nairobi and Western Kenya. In this proposal, we will compare workflow in the context of the Mobile WACh 
NEO RCT with workflow in an NLP-enabled variant of the same intervention (named AI-NEO). 
1.9 Supplements. Check all boxes that apply, to identify relevant Supplements that should be completed and 
uploaded to Zipline. 
This section is here instead of at the end of the form to reduce the risk of duplicating information in this IRB Protocol form that 
you will need to provide in these Supplements. 
 
Check all 
That Apply 
Type of Research 
Supplement Name 
 
 
 
 
Department of Defense 
The research involves Department of Defense funding, facilities, data, or 
personnel. 
SUPPLEMENT 
Department of Defense 
 
 
 
 
 
 
 
 
 
 
 
 
Department of Energy 
The research involves Department of Energy funding, facilities, data, or 
personnel. 
SUPPLEMENT 
Department of Energy 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 3. Precision-recall curves for urgency models 

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Drug, biologic, botanical, supplement 
Procedures involve the use of any drug, biologic, botanical or 
supplement, even if the item is not the focus of the proposed research 
SUPPLEMENT Drugs 
 
 
 
 
 
 
 
 
Emergency exception to informed consent  
Research that requires this special consent waiver for research involving 
more than minimal risk 
SUPPLEMENT Exception 
from Informed Consent 
for Emergency Research 
(EFIC) 
 
 
 
 
 
 
 
 
 
 
 
 
Genomic data sharing 
Genomic data are being collected and will be deposited in an external 
database (such as the NIH dbGaP database) for sharing with other 
researchers, and the UW is being asked to provide the required 
certification or to ensure that the consent forms can be certified 
SUPPLEMENT Genomic 
Data Sharing 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical device 
Procedures involve the use of any medical device, even if the device is 
not the focus of the proposed research, except when the device is FDA-
approved and is being used through a clinical facility in the manner for 
which it is approved 
SUPPLEMENT Devices 
 
 
 
 
 
 
 
 
 
 
 
 
Multi-site or collaborative study 
The UW IRB is being asked to review on behalf of one or more non-UW 
institutions in a multi-site or collaborative study. 
SUPPLEMENT Multi-site 
or Collaborative Research 
 
 
 
 
 
 
 
 
 
 
 
 
Non-UW Individual Investigators 
The UW IRB is being asked to review on behalf of one or more non-UW 
individuals who are not affiliated with another organization for the 
purpose of the research. 
SUPPLEMENT Non-UW 
Individual Investigators 
 
 
 
 
 
 
 
 
 
 
 
 
Other REDCap Installation Attestation for Electronic Consent 
The research will use a non-UW installation of REDCap for conducting 
and/or documenting informed consent. 
SUPPLEMENT Other 
REDCap Installation 
 
 
 
 
 
 
 
 
 
 
 
 
None of the above 
 
 
 
X 
 
 
 
 
 
1.10 Confirm by checking the box below that you will comply with the COVID requirements described on HSD’s COVID 
webpage, which are based on the location of the in-person study procedures and the vaccination status of study 
team members and study participants.  
Review the HSD website for current guidelines about which in-person research activities are allowable. 
 
 
X 
Confirmed 
 
 
2 PARTICIPANTS 
2.1 Participants. Describe the general characteristics of the subject populations or groups, including age range, 
gender, health status, and any other relevant characteristics. 
 
Aim 1: model validation 
• 
Current or previous nurse on a Mobile WACh study 
 
Aim 2: interface design 
• 
Current nurse on a Mobile WACh study or at ministry of health facility 

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Aim 3: Pilot 
• 
Pregnant women at 28-36 weeks gestation, age ≥14, able to receive daily SMS 
• 
Nurses working on delivering the AI-NEO pilot 
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. 
 
Aim 1: model validation 
• 
Currently or previously worked as a study nurse on a Mobile WACh study 
 
Aim 2: interface design 
• 
Currently working as a nurse on a Mobile WACh study or at ministry of health facility 
 
Aim 3: Pilot 
• 
Pregnant clients  
o Pregnant 
o 28-36 weeks gestation 
o Daily access to a mobile phone (own or shared) on the Safaricom network 
o Willing to receive SMS 
o Age ≥14 years 
o Able to read and respond to text messages in English, Kiswahili or Luo, or have someone in the 
household who can help 
• 
Nurses 
o Currently working as a nurse on AI-NEO study 
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. 
 
Aim 1: model validation 
• 
None 
 
Aim 2: interface design 
• 
None 
 
Aim 3: Pilot 
• 
Pregnant clients 
o Currently enrolled in another research study 
 
2.3 Prisoners. IRB approval is required in order to include prisoners in research, even when prisoners are not an 
intended target population. 
 
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 
à 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 
 

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Yes 
à If yes, describe the procedures and/or data collection that will continue with  
 
prisoner subjects 
 
      
2.4 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 GUIDANCE Prisoners for the definition of “prisoner”, which is not necessarily tied to the type of facility in which a 
person is residing. 
 
X No 
 
 
 
Yes 
à If yes, answer the following questions (i – iv). 
 
i. Describe the type of prisoners, and their location(s): 
 
      
 
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 is funded by one of these federal departments and agencies (Health & Human 
Services; Energy; Defense; Homeland Security; CIA; Social Security Administration), and/or 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 or pardon 
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 or pardon. 
 
 
Confirmed 
 
2.5 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 
 
 
 
 

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Pregnant women 
WORKSHEET Pregnant Women 
 
X 
 
 
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.  
 
This research proposal is focused specifically on using digital technologies (SMS) to improve neonatal 
mortality, practice of essential newborn care, care seeking behavior and maternal self-efficacy in Kenya. The 
research aims are specific to pregnant and postpartum women (including adolescent girls aged 14-17) and their 
babies. Kenyan regulations consider pregnant women age ³14 emancipated by pregnancy and able to give 
consent as independent adults. 
2.6 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 à If yes, name the tribe, tribal-focused organization, or similar community-based organization. The 
UW IRB expects that tribal/indigenous approval will be obtained before beginning the research. 
This may or may not involve approval from a tribal IRB. The study team and any 
collaborators/investigators are also responsible for identifying any tribal laws that may affect the 
research. 
 
 
 
 
      
2.7 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 
à If yes, these individuals are considered human subjects in the study. Describe them and what data 
will be collected about them. 
 
 
 
 
      

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2.8 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 
à 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 
à If yes, for each subject group, use the table below to provide the estimate of the maximum desired 
number of individuals (or other subject unit, such as families) who will complete the research. 
 
 
 
Group name/description 
Maximum desired number of individuals (or other 
subject unit, such as families) who will complete the 
research 
Provide numbers for the site(s) reviewed by the UW IRB and for 
the study-wide total number; example: 20/100 
 
Aim 1 nurses 
10 
 
Aim 2 nurses 
20 
 
Aim 3 pregnant cohort 
80 
 
Aim 3 nurses 
4 
 
      
      
 
      
       
 

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3 NON-UW RESEARCH SETTING  
Complete this section only if UW investigators and people named in the SUPPLEMENT: 
Non-UW Individual Investigators will conduct research procedures outside of UW and 
Harborview 
3.1 Reason for locations. Describe the reason(s) for choosing the locations.  
This is especially important when the research will occur in locations or with populations that may be vulnerable to 
exploitation. One of the three ethical principles the IRB must consider is justice: ensuring that reasonable, non-exploitative, 
and well-considered procedures are administered fairly, with a fair distribution of costs and potential benefits. 
 
      
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  
 
      
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. 
 
      
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. 
 
      

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3.5 If the PI is a student: Does the research involve traveling outside of the US?  
 
 
No 
 
 
 
Yes à 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. 
 
Note: Per UW Medicine policy, the UW Medicine eCare/MyChart system may not be used for research recruitment purposes. 
 
 
Aim 1 – model validation 
Recruitment: Nurses from former and ongoing Mobile WACh studies will be recruited by sharing information 
about the study in team meetings. Nurses will be informed that participation is voluntary.  
Screening: All nurses employed by Mobile WACh studies will be eligible to participate. 
 
Aim 2 – interface design 
Recruitment: Nurses from former and ongoing Mobile WACh studies will be recruited by sharing information 
about the study in team meetings. Additionally, nurses employed by MOH at study facilities will be recruited by 
sharing information about the study with the facility. Nurses will be informed that participation is voluntary. 
Screening: All nurses employed by Mobile WACh studies or the MOH facility will be eligible to participate.  
 
Aim 3 – AI-NEO pilot – cohort 
Recruitment: Women will be recruited when attending routine ANC, through in-person outreach by study staff. 
Women will be informed that participation is voluntary. 
Screening: Interested patients will be asked to provide verbal consent for screening (see Recruitment Script 1 Aim 
3), consenting women will be asked screening questions using an electronic questionnaire to assess eligibility and, 
if eligible (see inclusion criteria above), be invited to participate in the study.  
 
Aim 3 – AI-NEO pilot – nurse exit interview 
Recruitment: Nurses from the AI-NEO study will be recruited by sharing information about the interviews in team 
meetings. Nurses will be informed that participation is voluntary.  
Screening: All nurses employed by AI-NEO will be eligible to participate.  
4.2 Recruitment materials.  
 
a. What materials (if any) will be used to recruit and screen subjects? 
Examples: talking points for phone or in-person conversations; video or audio presentations; websites; social media 
messages; written materials such as letters, flyers for posting, brochures, or printed advertisements; questionnaires filled out 
by potential subjects. 
 
See talking points 1-3 for in-person recruitment. 

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b. Upload descriptions of each type of material (or the materials themselves) to Zipline. If letters or emails will be 
sent to any subjects, these should include a statement about how the subject’s name and contact information 
were obtained. No sensitive information about the person (such as a diagnosis of a medical condition) should be 
included in the letter. The text of these letters and emails must be uploaded to Zipline (i.e., a description will not 
suffice).  
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 
à If yes, describe the nature of the relationship. 
 
 
 
      
4.4 Payment to participants. The IRB must evaluate subject payment for the possibility that it will unduly influence 
subjects to participate. Refer to GUIDANCE Subject Payment when designing subject payment plans. Provide the 
following information about your plans for paying research subjects in the text box below or note that the information 
can be found in the consent form.  
• 
The total amount/value of the payment 
• 
Schedule/timing of the payment [i.e., when will subjects receive the payment(s)] 
• 
Purpose of the payment [e.g., reimbursement, compensation, incentive] 
• 
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 all of the above-listed information 
about payment, including the number and amount of payments, and especially 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.  
Researchers should review current UW Financial Management requirements about when Social Security Numbers must be 
collected, and when research payment must be reported to the UW Tax Office and the IRS: https://finance.uw.edu/ps/how-
pay/research-subjects. 
  
Aim 2 and 3 participants will receive payment as reimbursement for transport and compensation for their time. All 
participants will receive KSh 400 (approximately $4) per visit, at the end of the visit. Nurses participating in Aim 2 
will each participate in 2 focus groups and will receive a KSh 400 payment at the conclusion of each focus group. 
Pregnant clients participating in Aim 3 will attend 3 study visits and will receive a KSh 400 payment at the 

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conclusion of each study visit. Nurses participating in Aim 3 will attend one interview and will receive a KSh 400 
payment at the conclusion of the interview.  
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 
à If no, skip the rest of this section; go to question 5.1. 
 
X 
Yes 
à If yes, describe the data and/or specimens (including PHI) and whether it will be retained as part of 
the study data. 
 
 
 
A screening questionnaire will be used to collect data on eligibility and will include questions about 
age, pregnancy status, gestational age and phone access. 
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 
à If no, skip the rest of this section; go to question 5.1. 
 
X 
Yes 
à If yes, describe the consent process. 
 
 
 
We will obtain verbal consent for screening. 
 
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 
à If no, describe the information that will be provided during the 
consent process and for which procedures. 
 
 
We will approach women and inform them about the study (see 
talking points 3). 
 
 
Yes, written 
à If yes, and a written signature will be used to document consent: 
• 
Upload the consent form to Zipline. 
 
 
 
Yes, electronic 
à If yes, and an electronic signature will be used to document consent: 

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• 
Upload the consent form to Zipline. 
• 
If the eSignature process or method for recruiting and 
screening is different than for the main study procedures, use 
the questions about electronic consent in Section 8.3 and 8.4 to 
differentiate between recruiting/screening and main study 
electronic consent. If electronic consent will be used for 
recruiting/screening but not main study consent, use 8.3 and 
8.4 to describe eConsent and note that it is only for 
recruiting/screening. 
  
5 PROCEDURES 
5.1 Study procedures. Using lay language, provide a complete description of the study procedures, including the 
sequence, intervention or manipulation (if any), drug dosing information (if any), blood volumes and frequency of 
draws (if any), use of records, time required, and setting/location. If it is available: Upload a study flow sheet or 
table to Zipline.  
For studies comparing standards of care: It is important to accurately identify the research procedures. See UW IRB POLICY 
Risks of Harm from Standard Care and the draft guidance from the federal Office of Human Research Protections, “Guidance 
on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care”; October 20, 2014. 
Information about pediatric blood volume and frequency of draws that would qualify for expedited review can be found in this 
reference table on the Seattle Children’s IRB website. 
 
Aim 1 – model validation 
Nurses will self-administer an electronic tablet-based questionnaire that will present them with a series of 
participant messages and ask them to categorize each message’s urgency according to a provided definition. The 
questionnaire will also include open-ended questions to enter comments on each assessment. No identifiable 
information will be collected.  
 
Aim 2 – interface design 
We will conduct two iterative rounds of human-centered designed FGDs with nurses to determine how the AI-
NEO interface should designed (see Aim 2 FGD guide). The starting point will be the current Mobile WACh NEO 
user interface. Following informed consent, participants will complete a questionnaire using tablet-based Kobo 
Collect forms, regarding age, professional role, time in practice and technology access. In the first set of FGDs, we 
will explore nurses’ ideas for visually representing urgent messages in different parts of the user interface, for 
example having messages appear in a different color, having incoming messages sorted so that urgent messages 
appear at the top, and having urgent messages appear in a different part of the interface. After the first FGD, the 
study team will develop a prototype to illustrate possible displays. The same group of nurses will be invited to 
participate in the second FGD to evaluate the modified interface. FGDs will be conducted in English, in-person or 
by video conference, depending on COVID-19 restrictions and participant preferences. FGDs will be recorded and 
a note-taker will be present to capture general impressions of the discussion. Thereafter, notes will be compared 
to audio-recordings to fill in missing information and transcribed. Transcribed data will be de-identified and 
stored on a secure server. Recorded discussions will be destroyed no later than 6 months after conducting the 
FGD. Participants will be provided refreshments (if in-person) and KSh 400 (approximately $4) to compensate for 
their time and transportation expenses to each FGD, provided to participants at the conclusion of each FGD. 
 
Aim 3 – AI-NEO pilot 

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Intervention package: Our intervention is based on the 
Mobile WACh NEO intervention currently being tested 
in an RCT in Kenya (KNH ERC protocol P310/04/2019, 
UW IRB protocol STUDY00006395). Based on results of 
Aims 1 and 2, the Mobile WACh software will be 
updated to include NLP-based identification and display 
of urgent messages. Women will receive automated, 
theory-based SMS messages targeting the appropriate 
peripartum period (Figure 4) and will have the 
capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS 
will be delivered weekly. Two weeks prior to the participant’s estimated due date (EDD), daily messaging will 
begin, and will continue for two weeks after delivery is ascertained. If delivery is not confirmed by 43 weeks 
gestational age, the participant will be automatically moved to the postpartum messaging track. Thereafter, SMS 
will be delivered every other day for the remaining four weeks. Automated SMS will be delivered at times and in 
languages based on patient preferences. We have partnered with a local premium rate service provider (PRSP), 
Africa’s Talking, to provide SMS dialogue free of charge to participants.  Women who experience pregnancy or 
infant loss will be enrolled into an infant loss track where they will receive messages of support. All AI-NEO pilot 
participants will receive the intervention. 
 
Data collection: Participants will be followed from enrolment (28-36 weeks gestation) up to 18 weeks 
postpartum. All clinical care will be managed through the existing MCH infrastructure. The study visit schedule 
will be aligned to routine postpartum and infant visits: enrolment visit in pregnancy (28-36 weeks gestation), 2 
weeks postpartum and 6 weeks postpartum. Active tracing will be performed through phone calls and home visits 
to maximize completeness of data at study visits. Participants who do not report their delivery by 40 weeks will 
be contacted by phone, followed by home tracing if not reached by phone. Further, participants who are 1 week 
late for their 2-week or 6-week postpartum visits will be traced by phone. Participants who are 2 weeks late for 
their 6-week visit and cannot be reached by phone will be traced at their home. Participants who do not wish to 
come to clinic for their 2-week or 6-week visit will be offered to complete their visits by phone or at home in 
locations that ensure participant safety and confidentiality. This approach has been successful and acceptable in 
our previous studies in this population. During the consent process, study staff will collect contact information 
and permission to contact a family member or trusted individual who they may contact in case of long-term lack 
of communication from the participant. This person may be contacted as part of active tracing. 
 
A tablet-based screening questionnaire will be used to assess eligibility and collect sociodemographic 
characteristics. Following enrolment in the pilot, a tablet-based enrolment questionnaire using an open-source 
tablet-based data collection system (Kobo Collect) will be used to collect enrolment data including: 
demographics, clinical and sexual history, family planning, experience with SMS and technology, social support, 
intimate partner violence, and depression.  
 
At each visit, a standardized questionnaire will evaluate self-reported outcomes (Table 5), experience with the 
intervention, and participant clinical characteristics that may be associated with the outcomes, such as delivery 
experience, maternal and child health status, breastfeeding, care-seeking, cord care, depression and social 
support. Between study visits, data will be abstracted from patient clinic records to ascertain clinical outcomes 
such as deliveries, clinic/hospital visits, and infant or maternal deaths. The data will be abstracted from available 
facility records including MCH cards, facility registers (hospitalization, ANC, CWC, PNC), and EMR systems. The 
study nurses will review clinic records daily to check for deliveries and clinic visits from study participants. We 
have successfully employed this approach in a previous RCT, Mobile WACh-X 16,36.  In addition to contributing to 
ascertainment of trial outcomes, abstraction of clinic records will enable personalization of messaging, for 
example initiating postpartum messaging after a participant delivers. 
Figure 4. AI- NEO intervention outline 

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Medical extraction forms will be completed by data teams using REDCap electronic data management: delivery 
information, infant admissions, maternal health, infant health, maternal mortality, and infant mortality. 
 
When the study team learns of an infant death through an SMS message, phone call or clinic record review, the 
study team will contact the participant to arrange a visit to conduct a verbal autopsy. Verbal autopsies will be 
performed no earlier than 6 weeks after the infant death, either in the clinic or at the participant’s home based 
on their preference.  
 
Participants will be provided Ksh. 400 per visit to compensate for time and transportation expenses to participate 
in the study. All participants will be compensated KSh. 400 irrespective of whether the visit is conducted in 
person or virtually. We will provide this monetary compensation to each participant at the conclusion of each 
study visit. 
 
Data collection instruments: Data collection instruments will include forms to record data from participant 
surveys, to include:  
• 
Demographics  
• 
Experience with SMS and technology  
• 
Social support 
• 
Delivery report  
• 
Infant health 
• 
Maternal health 
• 
AI-NEO intervention acceptability 
 
Aim 3 – AI-NEO pilot –nurse exit interviews 
IDIs will be performed in a private area within the facility. Participants will meet a trained interviewer who will 
ask questions related to intervention acceptability and recommendations for change (see Aim 3 nurse interview 
guide) and take notes. Consent will be obtained from participants to take notes and audio record the discussion. 
The interviewer will describe procedures and norms for discussion and participation. Participants will be given a 
chance to ask questions regarding procedures prior to the discussion. Their socio-demographic information will 
be documented in separate forms. For postpartum client participants, socio-demographic information that will be 
captured includes: age, marital status, education level, employment, number of children. For nurses, 
demographic information will include age, level of training and years in profession. 
 
Interviews will be conducted in English, Kiswahili, or Luo depending on participant preferences. Thereafter, notes 
will be compared to audio-recordings to fill in missing information and transcribed to English (if necessary). 
Transcribed data will be de-identified. Tape-recorded discussions will be destroyed no later than 6 months after 
conducting the IDI. 
 
Participants will be provided refreshments and Ksh. 400 to compensate for time and transportation expenses to 
participate in the study. We will provide this monetary compensation to each participant at the conclusion of 
each interview. 
 
5.2 Recordings. Does the research involve creating audio or video recordings? 
 
 
No 
à If no, go to question 5.3. 
 
X Yes 
à If yes, verify that you have described what will be recorded in 5.1 and answer question a. 
 
a. Before recording, will consent for being recorded be obtained from subjects and any other 
individuals who may be recorded? 

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No 
à 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 
à If no, go to question 5.4. 
 
 
Yes 
à If yes, answer questions a through c. 
a. Describe the MRI scan(s). Specifically: 
• 
What is the purpose of the scan(s)? Examples: obtain research data; safety assessment 
associated with a research procedure. 
• 
Which subjects will receive an MRI scan? 
• 
Describe the minimum and maximum number of scans per subject, and over what time period 
the scans will occur. For example: all subjects will undergo two MRI scans, six months apart. 
 
      
b. MRI facility. At which facility(ies) will the MRI scans occur? Check all that apply. 
 
 
UWMC Radiology/Imaging Services (the UWMC clinical facility) 
 
 
DISC Diagnostic Imaging Sciences Center (UWMC research facility) 
 
 
CHN Center for Human Neuroscience MRI Center (Arts & Sciences 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: 
 
      
c. Personnel. For MRI scans that will be conducted at the DISC, CHN or BMIC research facilities: Indicate 
who will be responsible for operating the MRI scanner by checking all that apply. 
 
 
MRI technician who is formally qualified 
 
 
Researcher who has completed scanner operator training provided by a qualified MRI operator 
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. 
 
See attached data collection instruments: 
- 
Aim 1 validation questionnaire 
- 
Aim 2 FGD guide 
- 
Aim 3 pregnant client screening questionnaire 
- 
Aim 3 pregnant client enrollment questionnaire 

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- 
Aim 3 pregnant client follow-up questionnaire 
- 
Aim 3 pregnant client variables for data abstraction 
- 
Aim 3 pregnant client verbal autopsy questionnaire 
- 
Aim 3 nurse IDI guide 
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. 
 
The data will be obtained from subjects’ self-report and from their clinic based medical record.   
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 
à If yes, describe which identifiers and for which data/specimens.  
 
 
 
The PI and study staff will have access to identifiable information, including the 
participant’s full name and phone number. However, this identifiable date will be kept 
separate from all other data and will be kept in a password protected document on a study 
laptop that is kept in a locked cabinet when it is not being used.   
 
 
No 
à 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. 
 
 

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There are written policies and procedures for the repository/database/data 
management center that prohibit the release of the identifiers (or identifying link). This 
includes situations involving an Honest Broker. 
 
 
 
 
There are other legal requirements prohibiting the release of the identifiers or key. 
Describe them below. 
 
 
 
 
 
 
      
b. Will you or any study team members obtain any direct or indirect identifiers? 
 
X 
Yes 
à If yes, describe which identifiers and for which data/specimens. 
 
 
 
 
We will obtain identifiable information, including the participant’s full name and 
phone number. However, this identifiable date will be kept separate from all other data 
and will be kept in a password protected document on a study laptop that is kept in a 
locked cabinet when it is not being used.   
 
 
No 
à 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
 
 
 
 
We will store identifiers separately from study data but maintain a link with a code.  This 
will include all identifiable data – names, DOB and phone numbers.   
 
 

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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. 
NA 
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. 
For information about what constitutes the UW Covered Entity, see UW Medicine Compliance Patient Information Privacy Policy 
101 and diagram of the healthcare components. 
 
X No 
à If no, skip the rest of this question; go to question 5.8. 
 
 
Yes 
à 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 
 
 

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e. Will you obtain any HIPAA authorizations electronically (i.e., e-signature)? 
 
No 
  
Yes 
If ‘Yes’, confirm by checking the box that you have read and understand the ‘Special    
Considerations’ section of the GUIDANCE Electronic Informed Consent for information 
regarding the use of electronic signatures and HIPAA authorizations. 
 
Confirmed 
 
f. For which PHI will HIPAA authorization NOT be obtained from the subjects? 
 
      
 
Provide the following assurances by checking the boxes. 
 
 
The minimum necessary amount of PHI to accomplish the purposes described in this 
application will be accessed, obtained and/or used. 
 
 
 
 
 
 
The PHI will not be reused or disclosed to any other person or entity, except as required by 
law, for authorized oversight of the research study, or for other research for which the use or 
disclosure of PHI would be permitted. 
 
 
 
 
 
 
The HIPAA “accounting for disclosures” requirement will be fulfilled, if applicable. See UW 
Medicine Compliance Policy #104.  
 
 
 
 
 
 
 
 
There will be reasonable safeguards to protect against identifying, directly or indirectly, any 
patient in any report of the research. 
 
 
 
 
 
 
 
 
5.8 Genomic data sharing. Will the research obtain or generate genomic data? 
 
X No 
 
 
 
Yes 
à 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 
à If yes, complete the SUPPLEMENT Genomic Data Sharing and upload it to 
Zipline. 
5.9 Whole genome sequencing. For research involving biospecimens: Will the research include whole genome 
sequencing? 
Whole genome sequencing is sequencing of a human germline or somatic specimen with the intent to generate the genome or 
exome sequence of that specimen. 
 
X N
o 
 
 
 
Y
es 
 

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5.10 Possible secondary use or sharing of information, specimens, or subject contact information. Is it likely that the 
obtained or collected information, specimens, or subject contact information will be used for any of the following: 
• 
Future research not described in this application (in other words, secondary research) 
• 
Submission to a repository, registry, or database managed by the study team, colleagues, or others for 
research purposes 
• 
Sharing with others for their own research 
Please consider the broadest possible future plans and whether consent will be obtained now from the subjects 
for future sharing or research uses (which it may not be possible to describe in detail at this time). Answer YES 
even if future sharing or uses will use de-identified information or specimens. Answer NO if sharing is unlikely or if 
the only sharing will be through the NIH Genomic Data Sharing described in question 5.8. 
Many federal grants and contracts now require data or specimen sharing as a condition of funding, and many journals require 
data sharing as a condition of publication. “Sharing” may include (for example): informal arrangements to share banked 
data/specimens with other investigators; establishing a repository that will formally share with other researchers through 
written agreements; or sending data/specimens to a third party repository/archive/entity such as the Social Science Open 
Access Repository (SSOAR), or the UCLA Ethnomusicology Archive. 
 
 
N
o 
 
 
X Y
es 
à 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.  
 
All qualitative and quantitative data collected through this study will be stored for future 
use. Indirect identifiers (subject codes) will be retained. The link between direct and 
indirect identifiers will not be stored for future research. 
 
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.  
 
No direct identifiers will be shared with other researchers. 
 
c. Who will oversee and/or manage the sharing?  
 
The study PI, Keshet Ronen 
 
d. Describe the possible future uses, including limitations or restrictions (if any) on future uses or 
users. As stated above, consider the broadest possible uses. 
 
Examples: data will be used only for cardiovascular research; data will not be used for research on 
population origins. 
 
Data may be used to answer additional questions related to health and related mHealth 
interventions. These could be related to maternal and infant health or other conditions. 
SMS communications may be used to further develop natural language processing 
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e. Consent. Will consent be obtained now from subjects for the secondary use, banking and/or 
future sharing?  
 
 
No 
 
 
X 
Yes 
à If yes, be sure to include the information about this consent process in the 
consent form (if there is one) and in the answers to the consent questions in 
Section 8. 
 
 
f. Withdrawal. Will subjects be able to withdraw their data/specimens from secondary use, 
banking or sharing?  
 
 
No 
 
 
X 
Yes 
à If yes, describe how, and whether there are any limitations on withdrawal. 
 
Example: data can be withdrawn from the repository but cannot be retrieved after they 
are released. 
 
Participants may contact the study at any time to withdraw their permission 
to share their data. However, once shared, data cannot be retrieved. 
 
g. Agreements for sharing or release. Confirm by checking the box that the sharing or release will 
comply with UW (and, if applicable, UW Medicine) policies that require a formal agreement 
with the recipient for release of data or specimens to individuals or entities other than federal 
databases. 
 
Data Use Agreements or Gatekeeping forms are used for data; Material Transfer Agreements are used for 
specimens (or specimens plus data). Do not attach any template agreement forms; the IRB neither reviews nor 
approves them 
 
X Confirmed 
5.11 Communication with subjects during the study. Describe the types of communication (if any) the research team 
will have with already-enrolled subjects during the study. Provide a description instead of the actual materials 
themselves.   
Examples: email, texts, phone, or letter reminders about appointments or about returning study materials such as a 
questionnaire; requests to confirm contact information.  
 
Aim 1, 2 and 3 nurse interviews are cross-sectional, so no ongoing communication will take place with 
subjects after enrollment. 
 
Aim 3 pregnant client cohort is longitudinal. Intervention participants will receive text messages 
throughout the study as described above in section 5.1. Check-in calls will be made by nurses to 
participants who do not attend their final follow up visit. Participants’ secondary contacts will receive 
phone calls if participants cannot be reached. Further, home-based tracing will occur if there has not been 
other contact with the participant.  

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5.12 Future contact with subjects. Is there a plan to retain any contact information for subjects so that they can be 
contacted in the future? 
 
 
No 
 
 
X Yes 
à 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 would contact participants to request additional information for this study. We would also 
contact them to see if they would be interested in participating in any additional studies. All 
contact information will be limited to the current study team. 
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 
à If yes, describe the alternatives. 
 
 
 
      
5.14 Upload to Zipline all data collection forms (if any) that will be directly used by or with the subjects, and any 
scripts/talking points that will be used to collect the data. Do not include data collection forms that will be used to 
abstract data from other sources (such as medical or academic records), or video recordings. 
• 
Examples: survey, questionnaires, subject logs or diaries, focus group questions. 
• 
NOTE: Sometimes the IRB can approve the general content of surveys and other data collection instruments rather than the 
specific form itself. This prevents the need to submit a modification request for future minor changes that do not add new 
topics or increase the sensitivity of the questions. To request this general approval, use the text box below to identify the 
questionnaires/surveys/ etc. for which you are seeking this more general approval. Then briefly describe the scope of the 
topics that will be covered and the most personal and sensitive questions. The HSD staff person who screens this 
application will let you know whether this is sufficient or whether you will need to provide more information. 
• 
For materials that cannot be uploaded: upload screenshots or written descriptions that are sufficient to enable the IRB to 
understand the types of data that will be collected and the nature of the experience for the participant. You may also 
provide URLs (website addresses) or written descriptions below. Examples of materials that usually cannot be uploaded: 
mobile apps; computer-administered test; licensed and restricted standardized tests. 
• 
For data that will be gathered in an evolving way: This refers to data collection/questions that are not pre-determined but 
rather are shaped during interactions with participants in response to observations and responses made during those 
interactions. If this applies to the proposed research, provide a description of the process by which the data 
collection/questions will be established during the interactions with subjects, how the data collection/questions will be 
documented, the topics likely to be addressed, the most sensitive type of information likely to be gathered, and the 
limitations (if any) on topics that will be raised or pursued. 

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Use this text box (if desired) to provide: 
• 
Short written descriptions of materials that cannot be uploaded, such as URLs 
• 
A description of the process that will be used for data that will be gathered in an evolving way. 
• 
The general content of questionnaires, surveys and similar instruments for which general approval is being 
sought. (See the NOTE bullet point in the instructions above.) 
 
Data collection forms and example SMS messages are attached to this application.  We are seeking 
general approval for the content of these attachments and request that we are able to make minor word 
changes including removing and adding content that does not add to the sensitivity of the information 
(without approval).    
5.15 SARS-CoV-2 testing. Will the subjects be tested for the SARS-CoV-2 coronavirus? 
If the only testing is to screen the subjects (question 2.8), you do not need to answer this question 
 
X No 
 
 
 
Yes 
à If yes: 
• 
Name the testing lab 
• 
Confirm that the lab and its use of this test is CLIA-certified or certified by the Washington 
State Department of Health 
• 
Describe whether you will return the results to the participants and, if yes, who will do it and 
how (including any information you would provide to subjects with positive test results). 
 
 
 
 
      
 
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 
à If no, go to Section 8. 
 
X 
Yes 
à 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. 
 
 
 
 
Age 14-17. Legal age of consent in Kenya is 18, but pregnant minors are legally considered adults 
in Kenya (essential emancipation).  Therefore these women aged 14-17 do not require parental 
consent.   
We also include in this study the infant children of participants who will be newborns to 
approximately 6 weeks of age.  We will therefore be including all live born infants from 
participants.   
 
 
Don’t know 
àThis 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. 
 
 

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6.2 Parental permission. Parental permission means actively obtaining the permission of the parents. This is not the 
same as “passive” or “opt out” permission where it is assumed that parents are allowing their children to 
participate because they have been provided with information about the research and have not objected or 
returned a form indicating they don’t want their children to participate. 
a. Will parental permission be obtained for: 
 
 
All of the research procedures 
à Go to question 6.2b. 
 
 
 
 
 
 
None of the research procedures 
à Use the table below to provide justification, and skip question 
6.2b. 
 
 
 
 
 
 
Some of the research procedures 
à Use the table below to identify the procedures for which 
parental permission will not be obtained. 
 
X 
 
 
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 
Aim 3 pregnant 
participants age 
14-17 
Aim 3 intervention and collection of 
outcomes data and medical record data 
Participants are emancipated 
minors and can consent 
independently according to 
Kenyan regulations 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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.  
 
X 
 
 
 
 
This is all that is required for minimal risk research. 

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If both boxes are checked, explain: 
 
      
6.3 Children who are wards. Will any of the children be wards of the State or any other agency, institution, or entity? 
 
X 
No 
 
 
 
Yes 
à 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 
 
      
 
6.4 UW Office for Youth Programs Development and Support. If the project involves interaction (in-person or 
remotely) with individuals under the age of 18, researchers must comply with UW Administrative Policy 
Statement 10.13 and the requirements listed at this website. This includes activities that are deemed to be Not 
Research or Exempt. It does not apply to third-party led research (i.e., research conducted by a non-UW PI). 
Information and FAQs for researchers are available. 
 
This point is advisory only; there is no need to provide a response. 
 
 
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 
à Go to question 7.2. 
 
 
 
 
 
 
None of the research procedures and child groups 
à Use the table below to provide justification, 
then skip to question 7.6 
 
X 
 
 
 
 
Some of your research procedures and child groups 
à Use the table below to identify the 
procedures for which assent will not be 
obtained.  
 
 
 
 
Be sure to consider all research procedures and plans, including screening, future contact, and sharing/banking of data and 
specimens for future work. 

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Children Group1 
Describe the procedures or 
data/specimen collection (if 
any) for which assent will NOT 
be obtained 
Reason why assent will not be obtained 
Infant subject of enrolled 
participants  
Aim 3 collection of outcomes data 
and medical record data  
Infants are too young to assent  
Aim 3 pregnant participants 
age 14-17 
Aim 3 intervention and collection 
of outcomes data and medical 
record data  
Pregnant women aged 14-17 are considered adults 
who can legally consent  
      
      
      
      
      
      
      
      
      
Table footnotes 
1. If the answer is the same for all children groups or all procedures, collapse your answer across the groups and/or procedures. 
7.2 Assent process. Describe how assent will be obtained, for each child group. If the research involves children of 
different ages, answer separately for each group. If the children are non-English speakers, include a description of 
how their comprehension of the information will be evaluated. 
 
      
7.3 Dissent or resistance. Describe how a child’s objection or resistance to participation (including non-verbal 
indications) will be identified during the research, and what the response will be.  
 
      
7.4 E-consent. Will any electronic processes (email, websites, electronic signatures, etc.) be used to present assent 
information to subjects/and or to obtain documentation (signatures) of assent? If yes, describe how this will be 
done. 
 
      
7.5 Documentation of assent.  Which of the following statements describes whether documentation of assent will be 
obtained? 
 
 
None of the research procedures and child groups 
à Use the table below to provide justification, 
then go to question 7.5.b 
 
 
 
 
 
 
All of the research procedures and child groups 
à Go to question 7.5.a, do not complete the 
table 
 
 
 
 
 
 
Some of the research procedures and/or child groups 
à 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 
      
      
      
      
      
      

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

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

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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 
à If yes, use the table below to identify the procedures for which consent will not be obtained. “All” 
is an acceptable answer for some studies. 
 
 
Be sure to consider all research procedures and plans, including future contact, and sharing/banking of data and specimens for 
future work. 
Group1 
Describe the procedures or 
data/specimen collection (if any) 
for which there will be NO consent 
process 
Reason why consent will not be 
obtained 
Will subjects be 
provided with 
info about the 
research after 
they finish? 
 
 
 
YES 
NO 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If the answer is the same for all groups, collapse your answer across the groups and/or procedures. 
b. Describe the consent process, if consent will be obtained for any or all procedures, for any or all groups. 
Address groups and procedures separately if the consent processes are different. 
Be sure to include: 
• 
The location/setting where consent will be obtained 
• 
Who will obtain consent (refer to positions, roles, or titles, not names) 
• 
How subjects will be provided sufficient opportunity to discuss the study with the research team and consider 
participation 
 
Aim 1 – model validation 
Nurses who are interested in participating will provide written informed consent (see Consent 1 Aim 1). 
Consent will be obtained by the study coordinator in a private place at the study facility. 
 
Aim 2 – interface design 

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Interested nurses will be asked to provide written informed consent prior to scheduling the focus group 
discussion (see Consent 2 Aim 2). Consent will be obtained by the study coordinator or focus group facilitator, 
in a private place at the study facility.  
 
Aim 3 – AI-NEO pilot cohort 
Interested patients will be asked to provide verbal consent for screening (see Talking Points 3 Aim 3). Women 
interested in participating in the study will provide written informed consent to receive messages and complete 
quantitative and qualitative data collection (see Consent 3 Aim 3).  
 
Aim 3 – AI-NEO pilot - nurse exit interview 
Interested nurses will provide written informed consent to participate in an interview (see Consent 4 Aim 3). 
 
For all written consent processes, after a verbal explanation of the study, subjects will be given the consent 
document to read. Subjects will be given the opportunity to ask questions at any point during the consent 
process, and study staff will ask subjects before signing if they have any further questions. Subjects will be 
provided adequate opportunity to consider not participating by ensuring they understand the study procedures 
and type of information they will share. They will be informed that participation is completely voluntary and 
that they do not have to be part of the study if they do not want. They will be informed that they are free to 
decline participation without losing their regular medical care. They will also be assured that if they decide not 
to participate in the study, they can still join other research studies later. 
c. Comprehension. Describe the methods that will be used to ensure or test the subjects’ understanding of the 
information during the consent process. 
 
Consent and study details will be presented in a language that the subject understands. After providing study 
information and answering participant questions, the participants will be asked simple questions to ascertain 
their understanding of the study. 
d. Influence. Does the research involve any subject groups that might find it difficult to say “no” to participation 
because of the setting or their relationship with someone on the study team, even if they aren’t pressured to 
participate?   
Examples: Student participants being recruited into their teacher’s research; patients being recruited into their healthcare 
provider’s research, study team members who are participants; outpatients recruited from an outpatient surgery waiting 
room just prior to their surgery. 
 
 
No 
 
 
X 
Yes 
à 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. 
 
Study nurses may find it difficult to refuse participation due to concerns about professional 
consequences. We will reiterate that participation is completely voluntary and the PI will not 
receive information about which subjects agreed to participate. 

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e. Information provided is tailored to needs of subject population. Describe the basis for concluding that the 
information that will be provided to subjects (via written or oral methods) is what a reasonable member of the 
subject population(s) would want to know. If the research consent materials contain a key information section, 
also describe the basis for concluding that the  information presented in that section is that which is most likely 
to assist the selected subject population with making a decision. See GUIDANCE Key Information for Consent 
Materials. 
 
For example: Consultation with publications about research subjects’ preferences, disease-focused nonprofit groups, patient 
interest groups, or other researchers/study staff with experience with the specific population. It may also involve directly 
consulting selected members of the study population. 
 
Our collective study team has been conducting large studies in Kenya for the last 20 years. The consent form 
has been developed in collaboration with the population in the communities where we work. These consents are 
designed to be appropriate for subjects with lower literacy and study nurses highlight the key points and assess 
the participant’s comprehension. 
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. 
 
Subjects will be informed upon consent/assent that they will be able to decide to discontinue participation in the 
study at any time during the study if they choose, by notifying a study staff member. Intervention participants 
will be informed that they can withdraw from receiving SMS messages at any time.  
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 
à If no, skip to question 8.4 
 
 
Yes 
à 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. 

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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 the research team ensure continued accessibility of consent materials and information 
during the study? 
 
       
f. 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. 
 
       
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  
à Use the table below to provide justification then go to question 
8.5. 
 
 
 
 
 
 
All of the research procedures  
à Do not complete the table; go to question 8.4.b. 
 
 
 
 
 
 
Some of the research procedures 
à Use the table below to identify the procedures for which written 
documentation of consent will not be obtained from adult 
subjects.  
 
X 
 
 

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Adult 
subject 
group1 
Describe the procedures or data/specimen collection (if any) for which 
there will be NO documentation of consent 
Will they be 
provided with a 
written 
statement 
describing the 
research 
(optional)? 
 
 
YES 
NO 
Aim 3 
pregnant 
clients 
Eligibility screening 
 
 
 
 
 
 
 
 
 
 
X 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
      
      
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Table footnotes 
1. If the answer is the same for all adult groups or all procedures, collapse the answer across the groups and/or procedures. 
b. Electronic consent signature. For studies in which documentation of consent will be obtained: will subjects use 
an electronic method to provide their consent signature? 
• 
See the GUIDANCE Electronic Informed Consent for information about options (including REDCap e-signature and the 
DocuSign system) and any associated requirements. 
• 
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 
à If yes, indicate which methodology will be used. 
 
 
UW ITHS REDCap (excludes REDCap Mobile application, which is a separate software 
application for use with a mobile device for consent when internet service is absent or 
unreliable) 
 
 
Other REDCap 
installation 
à Please name the institutional version you will be using (e.g. 
Vanderbilt, Univ. of Cincinnati) in the field below and 
provide a completed SUPPLEMENT Other REDCap 
Installation with your submission. 
 
 
UW DocuSign 
 
 
 
Other 
à Please describe in the field below and provide a signed  
     TEMPLATE Other E-signature Attestation Letter with your   
     submission. 
 
      
b.1 Is this method legally valid in the jurisdiction where the research will occur? 
NOTE: UW ITHS REDCap (excludes REDCap Mobile application) and UW DocuSign have 
been vetted for compliance with WA State and federal laws regarding electronic 
signatures. 
 
 
No 
 
 
Yes à 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 àIf no, provide the rationale for why this is not required or necessary to protect  
subjects or the integrity of the research. Also, what would be the risks to the 
actual subject if somebody other than the intended signer provides the consent 
signature? 
 
      
 
 
Yes àIf yes, describe how subject identity will be verified, providing a non- technical  
 
description that the reviewer will understand. 
 
      
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. 
      

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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 
à 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. 
 
 
 
We will work with translators who are fluent in English, Swahili, and Luo to translate consent forms 
and messages throughout the study. Once consents and messages are translated in Swahili and Luo, 
they will be back-translated to English by another translator to ensure the meaning is preserved. 
 
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.  
 
We will not provide interpretation because we will translate all written communication into the 
preferred language of participants, which will also be spoken by study staff. 
 
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.  
 
We will work with translators who are fluent in English, Swahili, and Luo to translate consent 
forms and messages throughout the study. Once consents and messages are translated in Swahili 
and Luo, they will be back-translated to English by another translator to ensure the meaning is 
preserved. 
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. 
 
Study staff will read the form to potential subjects who are illiterate. If the potential participant cannot read the 
form herself, a witness (not a staff member who obtained the consent) must be present during the entire consent 
process and must sign the consent form. 
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 
 

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 Yes 
à If yes, describe what information and why. 
 
 
Example: It may be necessary to deceive subjects about the purpose of the study (describe why). 
 
      
 
a. Will subjects be informed beforehand that they will be unaware of or misled regarding the 
nature or purposes of the research? (Note: this is not necessarily required.) 
 
 
No 
 
 
 
Yes 
 
 
b. Will subjects be debriefed later? (Note: this is not necessarily required.) 
 
 
No 
 
 
 
Yes 
à 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 
à If no, go to question 8.9. 
 
 
Yes 
à 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. 
 
 
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. 
 
Asking subjects about sensitive topics (e.g. details about their sexual behavior or intimate partner violence history) 
may feel like an invasion of privacy to some individuals. To address these privacy concerns, subjects will be 
reminded that they are free to choose not to answer any question that makes them uncomfortable at any time.  
 
It will also be explained to participants that their name will not be linked to the information they provide. All 
participants will be assigned a study identification number (ID). Health information and phone numbers will be 
recorded and stored under this study ID. The list of participants linked to their study ID will be stored in binder in 
a locked cabinet separately from all other data. Only necessary study staff will have linkage to this linkage binder. 
The linkage is necessary to for data verification. Study analysts will receive only coded data. 
 
Participants will also be assured that data collected using Kobo Collect will be securely transmitted from the 
Android tablet used for data collection to the secure Kobo web server. All tablets and computers will be password-
protected and accessible only to study staff. The online system used to manage SMS messages will also be 
password-protected, stored on a secure web server, and accessible only to study staff. 
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 à If yes, will subject consent be obtained for this use? 
 
 
Yes 
 
 
 
No 
à If no, describe the steps that will be taken to protect subjects (or small groups of 
subjects) from being identifiable. 
 
 
 
 
      

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9.3 State mandatory reporting. Each state has reporting laws that require some types of individuals to report some 
kinds of abuse, and medical conditions that are under public health surveillance. These include: 
• 
Child abuse 
• 
Abuse, abandonment, neglect, or financial exploitation of a vulnerable adult 
• 
Sexual assault 
• 
Serious physical assault 
• 
Medical conditions subject to mandatory reporting (notification) for public health surveillance 
 
Are you or a member of the research team likely to learn of any of the above events or circumstances while 
conducting the research AND feel obligated to report it to state authorities? 
 
X No 
 
 
 
Yes 
à If yes, the UW IRB expects subjects to be informed of this possibility in the consent form or during 
the consent process, unless you provide a rationale for not doing so: 
 
 
 
 
 
      
9.4 Retention of identifiers and data. Check the box below to indicate assurance that any identifiers (or links between 
identifiers and data/specimens) and data that are part of the research records will not be destroyed until after the 
end of the applicable records retention requirements (e.g. Washington State; funding agency or sponsor; Food 
and Drug Administration). If it is important to say something about destruction of identifiers (or links to identifiers) 
in the consent form, state something like “the link between your identifier and the research data will be destroyed 
after the records retention period required by state and/or federal law.” 
This question can be left blank for conversion applications (existing paper applications that are being “converted” into a Zipline 
application.) 
 
See the “Research Data” sections of the following website for UW Records management for the Washington State research 
rectords retention schedules that apply in general to the UW (not involving UW Medicine data): 
http://f2.washington.edu/fm/recmgt/gs/research?title=R 
 
See the “Research Records and Data” information in Section 8 of this document for the retention schedules for UW Medicine 
Records: https://www.uwmedicine.org/recordsmanagementuwm-records-retention-schedule.pdf 
 
X 
Confirm 
9.5 Certificates of Confidentiality. Will a federal Certificate of Confidentiality be obtained for the research data? 
NOTE: Answer “No” if the study is funded by NIH or the CDC, because all NIH-funded and CDC-funded studies 
automatically have a Certificate. 
 
X No 
 
 
 
Yes 
 
9.6 Data and specimen security protections. Identify the data classifications and the security protections that will be 
provided for all sites where data will be collected, transmitted, or stored, referring to the 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. 
 
 
1) Level 2 data and security protections will be applied to data from nurses collected through questionnaires, 
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2) Level 3 data and security protections will be utilized for text message data received by the Mobile WACh 
messaging platform and responded to by the nurse and data from perinatal clients’ medical records, 
questionnaires and interviews.    
 
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. For example, if you intend to store subject 
identifiers with study data (not permitted under requirement U9 for Risk Levels 3-5), then indicate this in the 
box below (e.g., “We will not adhere to requirement U9 for screening data”). 
 
 
NA 
 
 
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.  
• 
Ensure applicable risk information from any Investigator Brochures, Drug Package Inserts, and/or Device Manuals is 
included in your description. 
• 
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. 
 
Physical: The study involves no medical interventions therefore we anticipate no risk of physical harm to 
participants. 
Other: SMS: There is a potential risk of disclosure of an individual’s person information to others in situations 
where phones are shared or stolen, which could lead to psychological or physical harm. We will minimize these 
risks through counseling in the informed consent process and ensuring women understand the type of messaging 
that will occur. We will remind participants that they may want to erase messages when sensitive or stigmatized 
topics are discussed. 
Access to clinical records: There could be a breach of confidentiality in the process of retrieving participants’ 
medical records. This will be mitigated by training all study staff on data management and storage to ensure 
confidentiality of sensitive data is maintained.  
Loss of Confidentiality in IDI and FGD: Participants will be notified that by participating in the IDI or FGD, loss 
of confidentiality is a possible risk of participating. They will be informed that every measure will be taken by the 
study team to ensure confidentiality. FGD participants will further be informed that while the study team will protect 
study data, the study team cannot control what other members of the FGD share with others outside of the group 
setting. 

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Discussion of sensitive topics: There is a risk of psychological distress due to discussing sensitive topics such as 
perinatal depression or maternal or infant illness by SMS or in interviews. Participants will be reminded that they 
are not obliged to answer every question or SMS message. Study staff will be trained in sensitive communication 
with participants.  
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 
à If no go to question 10.3 
 
 
Yes 
à If yes, answer the following questions: 
 
a. Risks. Describe the magnitude, probability, duration and/or reversibility of the risks. 
 
 
 
      
 
b. Steps to minimize risk. Describe the specific steps that will be taken to minimize the 
magnitude, probability, or duration of these risks. 
Examples: inform the subjects about the risks and how to minimize them; require a pregnancy test before 
and during the study; require subjects to use contraception; advise subjects about banking of sperm and 
ova. 
 
If the use of contraception will be required: describe the allowable methods and the time period when 
contraception must be used. 
 
 
 
      
 
c. Pregnancy. Describe what will be done if a subject (or a subject’s partner) becomes pregnant 
For example; will subjects be required to immediately notify study staff, so that the study procedures can 
be discontinue or modified, or for a discussion of risks, and/or referrals or counseling? 
 
 
 
      
10.3 MRI risk management. 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. Use of gadolinium. Will any of the MRI scans involve the use of a gadolinium-based contrast agent (GBCA?) 
 
X 
No 
 
 
 
Yes 
à 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 

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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 
b. Who will (1) calculate the dose of GBCA; (2) prepare it for injection; (3) insert and remove the IV catheter;  (4) 
administer the GBCA; and (5) monitor for any adverse effects of the GCBA? Also, what are the qualifications 
and training of these individual(s)? 
 
      
c. 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. 
 
      
d. 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.  
 
      
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 
à If yes, identify the procedures. 
 
 
 
      

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10.5 Subjects who will be under regional or general anesthesiology. Will any research procedures occur while 
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 
à If yes, check all the boxes that apply. 
 
 
 
 
Administration of any drug for research purposes 
 
 
 
 
 
 
 
 
 
 
Inserting an intra-venous (central or peripheral) or intra-arterial line for research purposes 
 
 
 
 
 
 
Obtaining samples of blood, urine, bone marrow or cerebrospinal fluid for research 
purposes 
 
 
 
 
 
 
Obtaining a research sample from tissue or organs that would not otherwise be removed 
during surgery 
 
 
 
 
 
 
Administration of a radio-isotope for research purposes** 
 
 
 
 
 
 
Implantation of an experimental device 
 
 
 
 
 
 
Other manipulations or procedures performed solely for research purposes (e.g., 
experimental liver dialysis, experimental brain stimulation) 
 
 
 
 
 
 
If any of the boxes are checked: 
Provide the name and institutional affiliation of a physician anesthesiologist who is a 
member of the research team or who will serve as a safety consultant about the interactions 
between the research procedures and the general or regional anesthesia of the subject-
patients. If the procedures will be performed at a UW Medicine facility or affiliate, the 
anesthesiologist must be a UW faculty member, and  the Vice Chair of Clinical Research in 
the UW Department of Anesthesiology and Pain Medicine must be consulted in advance for 
feasibility, safety and billing. 
 
 
      
 
 
** If the box about radio-isotopes is checked: the study team is responsible for informing in advance 
all appropriate clinical personnel (e.g., nurses, technicians, anesthesiologists, surgeons) about the 
administration and use of the radio-isotope, to ensure that any personal safety issues (e.g., 
pregnancy) can be appropriately addressed. This is a condition of IRB approval. 
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. For guidance on developing a DSMP, see the ITHS webpage on Data and 
Safety Monitoring Plans.  
 
See attached DSMP. 

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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. 
 
NA 
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. 
 
NA 
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.  
 
Women may benefit directly from the education that will be provided as part of the study. The intervention 
could potentially enhance women’s engagement with the health care system and optimize their follow-up and 
retention in care. Women will receive additional counseling, information and support. This has potential to 
improve both women’s and infants’ clinical outcomes. 
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 
à 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. 

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Actionable results may be identified in the enrollment and follow-up questionnaires 
completed by perinatal participants in Aim 3. We will screen participants for elevated 
depression symptoms. If these are detected they will be communicated to the participant 
and a referral made to local facility services. 
 
a.2. Explain which of these results will be offered to subjects.  
 
Findings of elevated symptoms on the depression instrument will be offered to subjects. 
 
a.3. Explain which results will not be offered to subjects and provide the rationale for not 
offering these results.  
 
Reasons not to offer the results might include: 
• 
There are serious questions regarding validity or reliability  
• 
Returning the results has the potential to cause bias 
• 
There are insufficient resources to communicate the results effectively and appropriately 
• 
Knowledge of the result could cause psychosocial harm to subjects 
 
None 
 
b. Is there a plan for offering subjects any results that are not clinically actionable? 
 
Examples: non-actionable genetic results, clinical tests in the normal range, experimental and/or uncertain results. 
 
X No 
 
 
 
Yes 
à 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. 
 
We are using the widely used and well-validated Edinburgh postpartum depression scale, which is 
routinely used in clinical care. 
 
d. Describe the process for communicating results to subjects and facilitating understanding of the results. In 
the description, include who will approach the participant with regard to the offer of results, who will 
communicate the result (if different), the circumstances, timing, and communication methods that will be 
used. 
 
The study nurse administering the questionnaire will communicate the results to the participant. Results 
will be communicated at the end of the questionnaire. Results will be phrased in such a way to ensure that 
the participant’s experience is normalized and the nurse communicates empathy. Communication of the 
result will be accompanied by referral to supportive resources. 
 
e. Describe any plans to share results with family members (e.g. in the event a subject becomes 
incapacitated or deceased). 
 
Results will only be shared with the participant. 
 
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 

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10.11 Commercial products or patents. Is it possible that a commercial product or patent could result from this 
study? 
 
X No 
 
 
 
Yes 
à 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. 
 
NA 
11.2 Costs to subjects. Describe any research-related costs for which subjects and/or their health insurance may be 
responsible (examples might include: CT scan required for research eligibility screening; co-pays; surgical costs 
when a subject is randomized to a specific procedure; cost of a device; travel and parking expenses that will not 
be reimbursed). 
 
No costs 
 
 
 
12 RESOURCES 
12.1 Faculty Advisor. (For researchers who are students, residents, 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.  
 
NA 
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. 

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12.3 UW Study team qualifications. Describe the qualifications and/or training for each UW study team member to 
fulfill their role on the study and perform study procedures. (You may be asked about non-UW study team 
members during the review; they should not be described here.) You may list these individuals by name, 
however if you list an individual by name, you will need to modify this application if that individual is replaced. 
Alternatively, you can describe study roles and the qualifications and training the PI or study leadership will 
require for any individual who might fill that role. The IRB will use this information to assess whether risks to 
subjects are minimized because study activities are being conducted by properly qualified and trained 
individuals. 
Describe: The role (or name of person), the study activities they will perform, and the qualifications or 
training that are relevant to performing those study activities. 
 
 
Examples:  
Research Study Coordinator: Obtain consent, administer surveys, blood draw. Will have previous experience 
coordinating clinical research and be a certified phlebotomist in WA. 
Undergraduate Research Assistant: Obtain consent, perform all study procedures. Will have had coursework in 
research methods, complete an orientation to human subjects protections given by the department, and will 
receive training from the PI or the graduate student project lead on obtaining consent and debriefing subjects. 
Acupuncturist: Perform acupuncture procedures and administer surveys. Must be licensed with WA State DoH 
and complete training in administering research surveys given by the project director, an experienced survey 
researcher. 
Co-Investigator: Supervise MRI and CT scan procedures and data interpretation, obtain consent. MD, specialty in 
interventional radiology and body imaging. 5-years clinical research experience.  
 
 
 
 
 
Mentors: Provide technical assistance and guidance to the principal investigator in developing and executing the 
study. This project is an NIH mentored career development award. Mentors have expertise in clinical trial 
conduct, digital health, and computer science. 
 
Site PI: Provide leadership and close guidance in study implementation. Medical doctor with 20 years’ experience 
in clinical medicine, and women’s health research in Kenya. 
 
Obstetrics and Gynecology Collaborator: Provide technical assistance on pilot intervention development. Medical 
doctor with 15 years’ experience in clinical medicine, women’s health research in Kenya and mHealth 
interventions. 
 
Computer Science Collaborators: Provide technical and analytical expertise, including developing natural 
language processing models, supporting human-centered design activities, and developing SMS system software. 
Masters or PhD degree training and 5-10 years’ expertise in human-centered design, computer science, and 
software development. 
 
12.4 Study team training and communication. Describe how it will be ensured that each study team member is 
adequately trained and informed about the research procedures and requirements (including any changes) as 
well as their research-related duties and functions. 
 
 
There is no study team. 
 
 
 
 
The study team will participate in an initial training at study launch to ensure all team members 
understand study procedures. The team will also have weekly calls and use e-mail communication to 
share any protocol updates.  

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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. 
 
Kenyatta National Hospital Ethics and Research Committee 
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 
à If yes, has the Office of Research made a determination regarding this SFI as it pertains to the 
proposed research? 
 
 
 
 
No 
à If no, contact the Office of Research (206.616.0804, research@uw.edu) for  
guidance on how to obtain the determination 
 
 
 
Yes 
à 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.