Comparing Screener vs. Survivor Role Models to Improve Colon Cancer Screening
Phase: NA
Conditions: Colonic Neoplasms, Colorectal Neoplasms, Colonic Diseases, Gastrointestinal Neoplasms
Sponsor: Washington University School of Medicine

 
 
 
 
COVER PAGE 
 
 
 
Comparing Screener vs. Survivor Role Models  
to Improve Colon Cancer Screening 
 
 
NCT02485561 
 
 
12/03/2015 

CRC Narratives - Internet 
PI: 
Amy McQueen 
IRB ID #: 201501019 
 
Project Details 
1. Demographics 
1.1 
Project Title: 
Evaluating Strategies to Present Colon Cancer Screening Information on the Internet 
1.2 
Short Title (required): 
CRC Narratives - Internet 
1.3 
Project is primarily: 
Social Science/Behavioral (includes History/Anthropology) 
1.4 
Type of Study: 
Other Interventional 
1.4.a 
Is your research study one in which one or more human subjects are prospectively 
assigned to one or more interventions (which may include placebo or other control) to 
evaluate the effects of those interventions on health-related biomedical or behavioral 
outcomes (NIH clinical trial definition). 
Yes 
1.5 
Select how you plan to obtain consent: 
•  Sign a consent document or a consent letter 
•  Letter or information sheet with no signature 
2. Source(s) of Support 
2.
1 
Source(s) of Support 
Type/S
ource 
Grant Title 
Nam
e of 
PI on 
Gran
t 
Status 
Federal 
Agency
  
NIH, 
Nationa
l 
COMPARING SCREENER VS. SURVIVOR ROLE MODELS TO 
IMPROVE COLON CANCER SCREENING 
Amy 
McQ
ueen 
AWAR
DED 

Institute
s of 
Health 
Attachment Name 
Category 
Version 
Date 
Attached 
McQueen Narratives 
submission.pdf 
Grant from funding source or private 
foundation/association 
1 
12/19/14 
3. Research Team 
3.1 
Principal Investigator 
Name 
E-mail 
Title 
School 
Amy McQueen amcqueen@dom.wustl.edu Assoc Prof of 
Medicine 
School Of 
Medicine 
3
.
2 
Team Members 
Research Team Members 
R
ol
e 
Name 
R
ol
e 
D
es
c 
Stu
den
t 
Email 
Title 
Sch
ool 
Depa
rtme
nt 
Co
nta
ct 
Cons
ent 
Proce
ss 
Invol
veme
nt 
Epi
c 
Co
nta
ct 
Per
son 
PI Amy 
McQueen, 
PHD 
No 
amcqueen@d
om.wustl.edu 
Assoc 
Prof of 
Medicine 
Sch
ool 
Of 
Me
dici
ne 
Int 
Med - 
Gen 
Medi
cal 
Scien
ces 
Yes 
Yes 
Charlene 
Caburnay, 
MPH, PHD 
ccaburnay@e
mail.wustl.ed
u 
Research 
Assistant 
Professor 
Geo
rge 
War
ren 
Bro
wn 
Sch
ool 
of 
Healt
h 
Com
m. 
Resea
rch 
Lab 
No 
No 

Soci
al 
Wor
k 
Balaji Golla, 
MS 
bgolla@emai
l.wustl.edu 
Programm
er/Databas
e 
Developer 
Geo
rge 
War
ren 
Bro
wn 
Sch
ool 
of 
Soci
al 
Wor
k 
Healt
h 
Com
m. 
Resea
rch 
Lab 
No 
No 
Matthew 
Kreuter, MPH, 
PHD 
mkreuter@e
mail.wustl.ed
u 
Eugene S. 
and 
Constance 
Kahn 
Family 
Professor 
Geo
rge 
War
ren 
Bro
wn 
Sch
ool 
of 
Soci
al 
Wor
k 
Publi
c 
Healt
h-
social 
Work 
No 
No 
Molly 
Loughran, BS 
mloughran@
email.wustl.e
du 
Non A&S 
Graduate 
Student 
Geo
rge 
War
ren 
Bro
wn 
Sch
ool 
of 
Soci
al 
Wor
k 
Healt
h 
Com
m. 
Resea
rch 
Lab 
No 
No 

 
Julianne Sefko, 
MPH 
 
 
jsefko@email
.wustl.edu 
Sr Clinical 
Research 
Coord 
Sch
ool 
Of 
Me
dici
ne 
Ortho
paedi
c 
Surge
ry 
Yes 
Yes 
 
Team Member Financial Interest 
Name 
Financial Interests 
Amy McQueen, PHD 
none 
Charlene Caburnay, MPH, PHD none 
Balaji Golla, MS 
none 
Matthew Kreuter, MPH, PHD 
none 
Molly Loughran, BS 
none 
Julianne Sefko, MPH 
none 
4. Other Institutional Reviews/Requirements 
4.1 
Do any of the objectives of this study involve the diagnosis, prevention, screening, 
evaluation, treatment or support of cancer patients? 
Yes 
4.2 
Are more than 30% of the patients involved in this study likely to have an active 
cancer diagnosis? 
No 
4.10 
Will a Certificate of confidentiality be used for this research? 
No 
4.11 
Does this project need to be registered on ClinicalTrials.gov? 
Yes 
4.11.a 
Who is the Responsible Party for registering this study in ClinicalTrials.gov? 
Principal Investigator 
4.19 
Mark all that apply to your study: 
Mark any service(s) you'd like to use: 
 • Participant Recruitment Services available through Recruitment 
Enhancement Core (REC) 
1. Protocol 

1.1 
Is there a separate, written protocol that will be submitted in addition to this form? 
(Note: a grant application is not considered to be a protocol) 
No 
1.2 
Select up to three key words below that best describe this research study: 
•  Education 
1.3 
Provide a short summary/abstract of the purpose and procedures of the study proposed 
in this IRB application. 
 
DO NOT include information on studies not proposed in this application. 
 
Use LAY terminology only. This must be easily understandable by IRB 
community members and nonscientists. 
 
DO NOT cut and paste technical abstracts from source of support applications 
that may not be understood by a general audience. 

This is a web-based pilot study examining the effects of narratives about colorectal 
cancer screeners on intentions and steps to colorectal cancer screening (CRCS) among 
average-risk adults who are non-adherent to CRCS guidelines (pre-test study IRB# 
201405069). Potential participants will complete a brief eligibility survey by phone or 
online then be invited to participate in the study. Eligible, consented participants will 
complete a baseline survey and read basic CRCS information then be randomly 
assigned within the website program to either 1) proceed directly to the post-
intervention survey or 2) view a portrait and read a narrative from an individual who 
got a colonoscopy and either did (“survivor”) or did not (“screener”) have cancer, 
before completing the post-intervention survey. Narratives will be written as first-
person testimonials based on similar stories posted online. Photos will be tailored to 
the participant (age group, gender, race/ethnicity). One month later, participants will 
be contacted to complete the follow-up survey online or by phone. A subset of these 
participants will be contacted for a three month follow-up survey online or by phone. 
1.4 
Specify your research question(s), study aims or hypotheses: 
Aim 1. Examine the direct effect of narratives on intentions and steps to CRCS 
behavior.  
Hypothesis 1: Narratives (vs. Information-only) will increase CRCS intentions 
and steps to behavior.  
Hypothesis 2: Screener (vs. survivor) narratives will increase CRCS intentions 
and steps to behavior.  
Aim 2. Examine mediators of narratives’ effects on intentions and steps to CRCS 
behavior.  
Hypothesis 3: Screener (vs. survivor) narratives will produce greater 
identification and self-efficacy and less negative affect and counterarguing 
(mediators) to indirectly influence CRCS intentions and steps to CRCS.  
Hypothesis 4: Survivor (vs. screener) narratives will produce greater perceptions 
of susceptibility to CRC, prevalence of CRC, social norms for CRCS, and 
negative affect, counterarguing (mediators) to indirectly influence CRCS 
intentions and steps to CRCS.  
Exploratory Aim 3. Estimate potential moderating effects of audience 
characteristics (e.g., sociodemographics, psychological dispositions).  

Hypothesis 5: People high in need for cognition will be more engaged and 
persuaded by narratives.  
1.5 
Background and significance and/or Preliminary studies related to this project: 
Colorectal cancer (CRC) is an important cause of morbidity and mortality in the 
US. Despite multiple recommended screening options, CRC screening (CRCS) 
rates are suboptimal. More effective interventions are needed to increase CRCS 
uptake. Narrative communications that depict events and consequences may have 
advantages over informational communication styles that present reasons and 
arguments. The inclusion of patient narratives in interventions and on the Internet 
are becoming ubiquitous and have far outpaced empirical research regarding how 
and for whom narratives are effective. Frequently, narratives take the form of role 
model stories or testimonials that promote behavior change. Breast cancer 
survivors’ testimonials have positively influenced women’s mammography use 
for early detection. However, survivors’ stories also may be perceived as 
inherently dissimilar and raise defenses among those concerned about (or in 
avoidance of) their cancer risk. For CRC, focusing on survivors also may 
undermine the message of preventing CRC through screening. Most people who 
are screened for CRC do not find any cancer and these “screeners” may be more 
influential role models. To improve future interventions that incorporate 
narratives, we need to identify the best role models (”survivors” vs. “screeners”) 
for increasing CRCS intentions and behaviors, and examine mechanisms of their 
influence. 
1.6 
Literature cited/references (if attaching a grant enter N/A): 
N/A 
1.7 
Describe EACH of your participant populations 
 
Include description of any control group(s) 
 
Specify the Inclusion/Exclusion criteria for EACH group 

Inclusion: Males and females adults aged 50-75 years old  
Exclusion criteria: Unable to read or speak English; prior diagnosis of cancer (except 
non-melanoma skin cancer), Crohn’s disease, inflammatory bowel disease or colitis; 
and adherent to colorectal cancer screening (CRCS) guidelines defined as a 
sigmoidoscopy (SIG) in the past 5 years, or a colonoscopy (COL) in the past 10 
years.  
1.8 
Check all materials/methods that will be used in recruiting participants: 
•  Telephone script  
•  Ads/Brochures/Posters/News Release/Fliers  
•  Email or letters  
•  Website or Social Media (printed pages)  
•  Other Materials  -  Potential participants may see study flyers posted through 
community organizations such as YMCAs, community centers, public libraries, public 
bulletin boards, health fairs, or other community events. They may also learn about 
the study through word of mouth or newspaper advertisements or newsletter 
announcements. We will also send flyers to Volunteer for Health registrants.  
•  Existing Registry/database  
   •  Other Existing Registry/database  -  Volunteer for Health, ResearchMatch.org  

•  Referral  
•  Medical Records or Other PHI  
Attachment Name 
Category 
Version 
Date 
Attached 
Brief Internet post 
text.rtf 
Recruitment Materials: 
Ads/Brochures/Posters/News 
Release/Fliers 
1 
06/25/15 
Narrative_poster 
modified.rtf 
Recruitment Materials: 
Ads/Brochures/Posters/News 
Release/Fliers 
9 
06/29/15 
Newspaper ad-
option2.rtf 
Recruitment Materials: 
Ads/Brochures/Posters/News 
Release/Fliers 
1 
06/25/15 
Newspaper ad-
option3.rtf 
Recruitment Materials: 
Ads/Brochures/Posters/News 
Release/Fliers 
1 
06/25/15 
Narrative_phone 
script.rtf  
Recruitment Script: Phone 
1 
12/18/14 
Newspaper ad-1-1.rtf 
Recruitment Materials: 
Ads/Brochures/Posters/News 
Release/Fliers 
7 
06/01/15 
McQueen facebook ad 
201501019.rtf 
Recruitment Materials: 
Ads/Brochures/Posters/News 
Release/Fliers 
1 
06/19/15 
McQueen201501019 
RPR website.rtf 
Recruitment Materials: 
Ads/Brochures/Posters/News 
Release/Fliers 
1 
06/19/15 
McQueen - 
Centerwatch.rtf  
Recruitment Materials: 
Ads/Brochures/Posters/News 
Release/Fliers 
1 
06/19/15 
Internet post text.rtf 
Recruitment Materials: 
Ads/Brochures/Posters/News 
Release/Fliers 
1 
06/25/15 
1.8.a 
List the individual data elements you will need to access/use from the patient or clinic 
records to identify potential participants for recruitment 
Names, email addresses and phone numbers will be used from the Volunteer for 
Health or HCRL registry in addition to age in order to identify potentially eligible 
individuals.  
1.8.b 
What is the plan for participant identifiers obtained to identify participants for 
recruitment? 
Identifiers for those who do NOT enroll will be destroyed at the earliest opportunity, 
consistent with the conduct of the research (for example when recruitment and 
enrollment are completed.) 
1.8.c 
Does the research team agree that the requested information will not be reused or 
disclosed to any other person or entity, except as required by law, for authorized 

oversight of the study, or for other research for which the use or disclosure of the 
requested information would be permitted by the HIPAA Privacy Rule? 
Yes 
1.9 
Will you use a screening log or other record that would include information on people 
who do not consent to participate in the study? 
Yes 
Attachment Name 
Category 
Version 
Date 
Attached 
Screening 
questions.docx 
Screening: Screening 
Log 
1 
01/07/15 
1.9.a 
Will the screening log be shared with individuals outside of the research team? 
No 
1.10 
Describe where the consent discussion will occur (check all that apply): 
•  Online 
1.11 
Participants and/or their legally authorized representative will have (check all that 
apply to the consent process and explain process in Question 1.12 below): 
•  As much time as they desire to consider enrolling in the study, including: 
 
An opportunity to thoroughly review the consent materials with 
knowledgeable members of the research team, and with family and/or 
friends as appropriate 
 
Sufficient time to have all of their questions answered 
1.12 
Provide a description of the enrollment and consent process in sequential order and 
address EACH of the bulleted points below: 
 
Describe each study population separately including control population 
 
Describe when recruitment and consent materials are used 
 
Indicate how much time individuals will have to consider participation 
 
Use THIRD person active voice. For example, "the principal investigator will 
identify potential participants, the study coordinator will discuss the study with 
participants over the telephone and schedule the first study visit, etc..." 
 
Describe the steps that will be taken by the research team to minimize the 
possibility of coercion or undue influence during the consent process 

Participants will be recruited through a variety of ways. They may see study flyers 
from clinicians, outpatient clinics, university buildings in the medical campus, 
employee health and wellness, or the Volunteer for Health office. They may also learn 
about the study through word of mouth or newspaper advertisements or newsletter 
announcements. Flyers may be distributed or posted through community organizations 
such as YMCAs, community centers, public libraries, public bulletin boards, health 
fairs, or other community events. The study will also be included in ClinicalTrials.gov 
and other volunteer research sites including the Volunteer for Health website, 
Facebook page, and Center Watch, and external sites such as ResearchMatch.org, 
ResearchRegistry.pitt.edu, CreateTheGood.org, SocialPsychology.org, 
StudyResponse.net, Psych.Hanover.edu/Research/exponent, and 
PioneersResearch.org. Participants using independent research study search engines 

(often within university or health system websites) may find our study and others 
posted on ClinicalTrials.gov without going directly to that site. Participants may also 
be recruited through colleague referrals or by research staff in proactive recruitment 
calls to people in volunteer registries.  
Interested individuals can learn about the study purpose, requirements, and 
compensation by reading the informed consent form on the website or speaking to 
research staff who can also answer any questions that individuals may have. Interested 
individuals will complete an eligibility survey on the website or by phone and if 
eligible, may consent to participate after reading an informed consent form. 
Participants may choose to complete the interview at a location of their choice using 
their own internet-enabled device. If they do not have access to a computer, they may 
complete the interview by appointment with study staff and use a University 
computer.  
There should be no coercion or undue influence from research staff on potential 
participants as they have no relationship. Additionally, all staff are experienced with 
recruitment and protecting the rights of human subjects.  
1.13 
Provide a detailed description in sequential order of the study procedures following 
the consent process - DO NOT cut and paste from the Consent Document. 
Describe study populations separately if they will be participating in different 
procedures 
DESCRIBE: 
 
Control populations, if applicable 
 
Any randomization, if applicable 
 
What participants will be asked to do/what happens in the study (in sequential 
order) 
 
The time period over which procedures will occur 
 
Long-term follow-up and how it occurs 

Participants will complete a baseline web-based survey and read basic CRCS 
information then, be randomly assigned within the website program to either 1) 
proceed directly to the post-intervention survey or 2) view a portrait and read a 
narrative of an individual who got a colonoscopy and either did (“survivor”) or did not 
(“screener”) have cancer, before completing the post-intervention survey. Interested 
participants without access to a computer may schedule a time to come to our office to 
complete the surveys on a study computer, otherwise participants can complete the 
study anywhere they have access to a computer and internet connection. This session 
will not exceed 30 minutes and participants will be paid $20 for their time. One month 
later, participants will be contacted to complete a follow-up survey online or by 
phone. This one-month follow-up session will not exceed 10 minutes and participants 
will be paid $10 for their time. A subset of participants may complete a six-month and 
twelve-month follow-up survey. Each of these additional follow-up sessions will not 
exceed 10 minutes and participants will be paid $5 for their time. 
1.14 
Will participants be randomized? 

Yes 
1.15 
Will any of the following be used to collect information from the participant or 
others? 
 
Screening questions or screening/eligibility questionnaires 
 
Surveys 
 
Questionnaires 
 
Stimuli 
 
Any other written assessments 

Yes 
Attachment Name 
Category 
Version 
Date 
Attached 
Post-Intervention survey.docx 
Subject Data 
Collection 
Instruments 
1 
01/07/15 
Baseline survey.docx  
Subject Data 
Collection 
Instruments 
1 
01/07/15 
Narrative_6moFollowupSurvey.docx  
Subject Data 
Collection 
Instruments 
1 
10/29/15 
Follow-up survey-1 (1) (2).docx  
Subject Data 
Collection 
Instruments 
5 
10/29/15 
Narrative_12moFollowupSurvey 
(5).docx  
Subject Data 
Collection 
Instruments 
6 
06/27/16 
1.16 
Does this project involve creating any audio, video, or photographs? 
No 
1.17 
Does the study include any form of deception (e.g., providing participants with false 
information, misleading information, or withholding information about certain study 
procedures)? 
Examples: 
 
Procedure includes a cover story that provides a plausible but inaccurate 
account of the purposes of the research. 
 
Participants will be provided with false information regarding the particular 
behaviors of interest in the research. 
 
Procedures include a confederate pretending to be another participant in the 
study. 
 
Participants will be told that the research includes completion of a particular 
task, when in fact, that task will not be administered. 
 
Study is designed to introduce a new procedure (or task) that participants are 
not initially told about. 


No 
1.18 
Indicate any payments or reimbursements to participants (check all that apply) 
 
Check 
1.19 
Does this study have a plan to have an individual or committee review combined data 
from all participants on a periodic basis (such as summary or aggregate safety and/or 
efficacy data)? 
No 
1.20 
What have you done to minimize any risks? 
•  No forseeable risks 
1.21 
What are the potential benefits related to this project for: 
 
the participant (if any) 
 
benefits to society (if any) 
 
 
Participants may or may not benefit from being in this study. Participants may 
gain knowledge of colorectal cancer and screening options.  
Our results may change how CRC screeners’ narratives are valued, used, and 
potentially tailored for different audiences to promote CRCS among non-adherent 
adults. We hope that, in the future, other people might benefit from this study 
because we will learn better ways to present information to educate and motivate 
adults to get screened for colon cancer. 
1.22 
Provide a summary of the analysis methods you will use, including, if applicable, 
the data points or outcomes you will analyze. 
Participants assigned to study arms are expected to be equivalent on baseline 
measures; any differences will be included as covariates in analyses. We also will 
test for differential loss to follow-up, and compare results from intent-to-treat vs. 
complete-data analyses. To test Aim 1 hypotheses, we will conduct analyses of 
variance or covariance in SPSS, as appropriate. Baseline intention will be 
included as a covariate of later intention. Planned contrasts will compare (1) the 
information only vs. the pooled narrative conditions, and (2) survivor vs. screener 
narratives. We chose intention as the main outcome in this pilot study because it 
is a necessary determinant of CRCS behavior. We will also examine steps to 
CRCS (e.g., using or seeking CRCS information, discussing CRCS with others) 
as important intermediate outcomes of CRCS adherence. For Aim 2, to test 
indirect effects of narratives and provide empirical support for our conceptual 
model, we will use structural equation modeling (SEM) with Mplus software 
consistent with our past work. We will use recommended criteria for assessing 
model fit and statistical tests for identifying the magnitude and significance of 
multiple mediators (indirect effects). SEM can parsimoniously evaluate multiple 
mediators and outcomes in a single model. To test our conceptual model, we will 
examine message elaboration and CRCS determinants as mediators (from the 
Post-intervention Survey) of the effect of narratives on intentions and behaviors 
(from the Follow-up Survey). We propose to use manifest variables and we will 
create exogenous dummy variables to compare study groups. We expect stronger 

effects of study condition on mediators than on outcomes and are particularly 
interested in differences in perceived risk, worry, and prevalence of CRC, 
affective reactions to narratives, and defenses. For Aim 3, two-way interactions 
between study condition and individual characteristics will be explored using 
GLM analyses in SPSS for mediators and outcomes. Post-hoc group comparisons 
and interaction plots will be used to describe any significant associations. We are 
especially interested in noting any differences in narrative effects by gender or 
race to address the need for stratified interventions or analyses in a future R01. 
1.23 
Provide the rationale or power analysis to support the number of participants 
proposed to complete this study. 
Using post-intervention intention as a main outcome for Aim 1, assuming a mean 
score of 3.5 and a standard deviation of 1.0 on a 1-5 scale, there is >80% power 
to detect a 0.3 mean difference between survivor vs. screener narratives (Hyp2) 
with a sample size of 360 (120 per condition) at p< 0.05. Thus, we propose to 
recruit 500 participants (~167 per condition) during the 2-year study to provide 
sufficient power for any loss to follow up (<20%). Assuming 400 participants 
provide complete data, we can test our conceptual model (Figure 1) using 
structural equation modeling. We will have sufficient power (>.80) to detect 
small associations (beta ≥ .19) with mediators, and indirect effects as small as αβ 
≥ .07 as statistically significant. 
1.25 
Will any data from this project be stored for use in future research studies? 
No 
1.26 
Does this project involve the collection or use of biological samples? 
No 
1.27 
Are you requesting institutional certification to contribute human data or samples to a 
repository or database for broad sharing (public or restricted access)? 
No 
2. Participants 
2.1 
Will there be any adult participants? 
Yes 
2.1.a 
How many adult participants do you expect to consent or enroll under a waiver 
for this project? 
600 
2.1.b 
What is the age of the youngest adult participant? 
50.0 
2.1.c 
What is the age of the oldest adult participant? 
75.0 
2.2 
Will there be any minor participants? 
No 
2.3 
Will there be any emancipated minor participants? 
No 
2.7 
Do you plan to recruit/enroll non-English speaking people? 
No 
2.8 
Do you propose to enroll any of the following in this study as participants? 

 
Employee of the PI or employee of a research team member 
 
Individual supervised by PI or supervised by member of research team 
 
Individual subordinate to the PI or subordinate to any member of the research 
team 
 
Student or trainee under the direction of the PI or under the direction of a 
member of the research team 

No 
2.9 
Is this project about pregnant women? 
No 
2.10 
Will this project involve fetuses? 
No 
2.11 
Does this project involve the use of fetal tissue from any source? 
No 
2.12 
Does this project recruit adult participants who may be incompetent or have limited 
decision-making capacity on initial enrollment into the study? 
No 
2.13 
Does this project involve prisoners as participants? 
No 
3. Performance Sites 
3.1 
Indicate type of site(s) where research will occur (check all that apply): 
•  Academic Institution 
•  Other  -  Online 
3.2 
Where will project procedures take place (check all that apply)? 
 
School of Medicine 
 
Other WUSTL campus site - Division of General Medical Sciences in the 
School of Medicine, Health Communication Research Laboratory at Brown 
School of Social Work 
3.3 
Is this project also being conducted by other researchers at their own sites (e.g. a 
multi-site collaborative project)? 
No 
5. Privacy & Confidentiality 
5.1 
Indicate your plans to protect the privacy interests of the participants during the 
conduct of the study (check all that apply): 
•  Only the minimum necessary private information is collected for the purposes of 
the study 
•  Any procedures or interventions conducted as part of the study will be conducted in 
private setting to the extent possible 

•  Recruitment/consent will occur in a private setting 
•  Participants will be able to ask questions in a private setting 
5.2 
Are you collecting or using the Social Security Number of any participants for any 
purpose? 
Yes 
5.2.a 
Provide the intended usage of SSN: 
 
To provide compensation to participants 
5.3 
Project uses paper or hard copy consents, surveys, data collection forms, research 
subject binders, or other hard copy materials (check all that apply): 
Yes 
•  All materials are stored in secured environment 
•  Access is limited to research team members only 
5.4 
Project collects, stores and/or transmits electronic data on mobile devices, desktop 
computers, servers including cloud servers, email, or any other information in 
electronic form (check all that apply): 
Yes 
•  Access is limited to research team only 
•  Transmitted using recognized security for electronic submission 
5.5 
Project collects or uses biologic specimens (check all that apply): 
No 
5.6 
Identify any additional protections in place for data and or samples (check all that 
apply): 
•  Formal research staff training process