Systematic Pediatric Assessment of Rome Criteria
Phase: NA
Conditions: Functional Gastrointestinal Disorders
Sponsor: Indiana University

 
 
 
Systematic Pediatric Assessment of Rome Criteria (SPARC)  
 
Principal Investigator: William Bennett MD  
 
IRB Protocol # 1811325201 
 
NCT04773158 
 
 

#1811325201 - Systematic Pediatric Assessment of Rome 
Criteria (SPARC) 
Protocol Information 
Review Type 
Expedited 
Status 
Approved 
Approval Date 
Sep 10, 2024 
Continuing Review Date 
Dec 05, 2020 
Expiration Date 
-- 
Initial Approval Date 
Dec 05, 2018 
Initial Review Type 
Expedited 
Feedback 
Approval Comment 
Amendment A017 This research is approved under the following expedited categories: - Category 5 - 
Category 7  
Protocol Amendment Form 
Amendment Request 
4000 
Select your Protocol Type 
Expedited/Full Board  
4012 
Amendment Number 
A017 
4001 
Select the types of changes being made. 
Personnel update 
4002 
Does this amendment include a change in PI? 

No 
 
General Information 
Principal Investigator 
Bennett, William 
Lead Unit 
IN-PGAS - PED-GASTROINTESTINAL DISEASES 
Protocol Title 
Systematic Pediatric Assessment of Rome Criteria (SPARC) 
Personnel 
Person 
Bennett, William 
Email Address 
webjr@iupui.edu 
Researcher Role 
Principal Investigator (PI) 
Home Unit 
IN-PGAS - PED-GASTROINTESTINAL DISEASES 
Contact Roles 
 
Permissions 
Full Access 
Affiliation Type 
IU 
Training 
• 
Biomedical Researcher - Stage 4 - CITI 
• 
08/07/20 - 08/06/25 
Status: Approved 
Personnel Attachments 
Protocol Type 
Select Protocol Type 
Expedited 
Participant Type 
Participant Information 
Participant Type 
Children 

Participant Number 
10000 
Participant Type 
Economically/Educationally Disadvantaged 
Participant Number 
600 
Participant Type 
Total 
Participant Number 
10600 
Organizations 
Organizations List 
Organization 
ESKENAZI HEALTH CENTER 
Organization 
INDIANA UNIVERSITY 
Funding 
Will the study be funded, fully or partly by, any of the following 
sources (this includes pass through funding)? Select all that apply. 
Federal funding 
Funding Sources 
Funding Source 
NATIONAL INSTITUTE OF DIABETES, DIGESTIVE & KIDNEY 
Conflicts of Interest 
q134 
Are any of the investigators listed in the personnel section aware of an 
institutional conflict of interest which could affect or be affected by 
this research? 
No 
 
q24901 
Do any of the investigators listed in the Personnel section (or their 
immediate family members) have a significant financial interest which 
could affect this research? 

No 
q24905 
Does the Principal Investigator affirm all investigators listed as 
personnel on this protocol have agreed to participate in this project, 
are aware of their status and role, and have been adequately trained 
to participate in the project? 
Yes 
A-Level of Review 
q720 
Does any research activity in this study present more than minimal risk 
to human subjects? 
No.The research may qualify for Expedited review if all research procedures fall into 
one of the categories below. 
 
q721 
Check all category(ies) which apply to this research. 
Category 5 - Research involving materials (data, documents, records, or specimens) 
that have been collected, or will be collected solely for nonresearch purposes 
Category 7 - Research on individual or group characteristics or behavior, or research 
employing survey, interview, oral history, focus group, program evaluation, human 
factors evaluation, or quality assurance methodologies 
 
q724 
Will the researchers be using a data collection form?  
No 
 
q725 
List all data points that will be recorded or collected. 
FGID Module: Data points collected for participation in the retrospective review of 
FGID module data include date(s) of visit, physician name, patient vitals and 
demographics, contact information, patient/parent answers to GI questions, who is 
answering the questions (parent or patient or both), and physician notes about GI 
diagnoses, treatments, and recommendations. Tool Usability Questionnaire: Data 
points collected in the Gastrointestinal Symptom Survey Tool and FGID Module (as 
above) Survey (online and phone): In addition to the FGID Module data points above, 
we will use parent and patient answers to the phone survey, along with parent-
reported demographics. Baseline retrospective review: DOB, date/diagnosis (ICD 

codes), Eskenazi clinic(s) of care Health care utilization retrospective review: • The 
presence of outpatient sick visits within the Eskenazi system clinic for any complaint 
• The presence of outpatient sick visits within the Eskenazi system clinic with an 
associated GI billing code • The presence of visits to statewide providers, including 
inpatient hospital stays, outpatient clinic visits, and emergency room visits. • The 
occurrence of any GI-related testing and procedures – specifically radiologic, 
laboratory testing, endoscopy, and surgical procedures related to GI diagnoses • The 
use of any medications prescribed to treat Rome IV diagnoses – specifically acid-
suppressants, antispasmodics, antidepressants, stool softeners and laxatives, and 
pro-motility agents. 
q23340 
Would identification of subjects and/or their responses reasonably 
place them at risk for any of the following (check any that apply): 
None 
B-Lay Summary Research Design 
q22122 
Describe the purpose of this study in lay terms, including research 
question(s) and hypothesis.  
Functional gastrointestinal disorders (FGIDs) are extremely common in children and 
adolescents, and represent a wide range of disorders that are apparently related to 
the gastrointestinal tract, but which have no clear structural, anatomic, or 
histopathologic cause. FGIDs represent an enormous burden on patients and 
families, and patients with these functional disorders have much higher health care 
utilization and related costs. FGIDs are diagnosed according to the symptom-based 
Rome criteria. The Rome criteria have been developed by experts in pediatric 
functional disease through literature review and a consensus process. Unfortunately, 
FGIDs are often diagnosed incorrectly by primary care providers and patients often 
wait months to years before a correct diagnosis is made, and effective treatment is 
begun. Furthermore, primary care providers are often unaware of recent guideline 
changes or the evidence base for children with FGIDs, leading to overuse of testing, 
inappropriate or ineffective treatment, and increased costs. Given this information, it 
is essential that we develop interventions that target pediatric primary care 
providers to improve their care for children with FGIDs. We propose that using a 
Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for 
diagnosis and evidence-based care for FGIDs will improve the (1) accuracy of 
diagnosis and (2) effectiveness of clinical care, thereby improving clinical outcomes 
and reducing the economic burden of FGIDs in children. Once a FGID screening and 
care module within Epic is developed and tested, when a patient is scheduled to see 

or presents to any primary care clinics in the Eskenazi health system which support 
general pediatric care, the patient (and/or parent) will be asked to complete FGID 
screening questions prior their provider visit as part of standard care. Rules have 
been established within EPIC to determine how often patients receive the FGID 
questionnaire to avoid redundancy, inappropriate use, and/or burden to the patient. 
Screening results will be available to physicians immediately, and physicians in the 
intervention clinics will have access to specific guidance for the diagnosis and 
treatment/management of the FGID, as well as information to share with families. 
Physicians may chose to document their FGID assessments and plans in the patient's 
EMR via EPIC. We hypothesize that automation of screening, diagnosis, and 
management of FGIDs will result in improved resolution of FGIDs (primary outcome), 
as well as decreased utilization of medical services (secondary outcomes). We 
propose to test this hypothesis using the following specific aims: Aim 1: Develop 
computer-based decision support system, to screen children 0 to 18 years of age for 
functional gastrointestinal disorders (FGIDs) using the Rome IV criteria, and provide 
guidance regarding diagnosis and management of probable FGIDs. (Please note that 
Aim 1 does not involve the use of human subjects/PHI.) Aim 2: Demonstrate the 
feasibility and effectiveness of thie FGID Module to improve clinical care measures 
(e.g., resolution of Rome IV criteria) and reduce utilization of healthcare services (e.g. 
repeat outpatient visits, ED visits). 
 
q22123 
List and describe all research interactions and/or interventions, 
including the frequency and duration of procedures, and length of 
participation for individual subjects. 
In order to determine the effect of the FGID decision support module, we will 
complete the following study procedures: FGID module (data review): There is no 
contact with subjects for this portion of the study; this is a retrospective and 
prospective review of data. We will pull retrospective and prospective patient data 
from the EMR for FGID screening, diagnosis, and treatment in order to analyze 
module process and outcome data, including any difference in physician behavior at 
control vs. intervention clinics in the diagnosis, treatment, and symptom resolution 
of FGIDs. Control verses intervention clinic will be determined by cluster 
randomization at the clinic site level. A002: In order to determine the usability, 
"patient-friendliness" of this module, we will collect qualitative feedback about of 
the user's experience from a subset of 50 families who completed it. This one time 
questionnaire will be administered by REDCap survey. A003:Tool usability 
questionnaire: Expand enrollment aim to 50 to 100 participants. Survey (online and 

phone): We will also conduct surveys with a subset of parents of patients and 
patients with a positive FGID screen to assess symptoms, parental concern, and 
parent satisfaction. With the parent's permission, patients ages 10-17 will also be 
invited to participate in the phone survey about their symptoms and satisfaction. The 
surveys will be conducted over various time points: approximately 1, 3, 6, and 12 
months after the positive screen for a FGID. (We anticipate conducting surveys with 
a maximum of 600 parents/legal guardians and older patients.) Survey responses can 
be obtained from the parent, parent and child, or child only (age 10-17). 
Determination as to who completeness the questionnaire at each time point will be 
influenced by family availability and desire to not place burden. All participants will 
be offered the option to complete surveys online or by phone to accommodate their 
changing needs at the designated timepoints. The patient facing online surveys will 
be bilingual (English and Spanish) and will include the same data elements as the 
instruments designated for the demographics and the diagnosis specific follow up 
questionnaires . The survey version will include participant instructions/prompts to 
guide independent completion. A012: To offer potential participants two different 
channels for participation, enrollment and surveys will be offered electronically and 
by phone. Online enrollment will be deployed in 2 phases. Phase 1 (A012) will be for 
English and the Phase 2 for Spanish. Future amendment will be submitted to initiate 
Phase 2. For those who read the E-Consent but opt to not consent/participate, the 
person reading the consent will be asked one additional question in an effort to 
better understand the decision not to participate. This question is voluntary and 
included in the REDCap E-Consent draft. A014: To remain in compliance with 
University and IU Health Policies, we will inform participants that personal email is 
not a secure means of communication and obtain their permission to use email for 
communications. Baseline retrospective review: We will submit a query to the 
Indiana Health Information Exchange at the Regenstrief Institute for FGID diagnosis 
data to determine the prevalence for each functional GI disorder diagnosed by the 
primary care provider prior to the implementation of the FGIDs Modules. Health care 
utilization retrospective review: We will query Epic, and Indiana Network for Patient 
Care (INPC) via RMRS for data to assess health care utilization including outpatient 
visits, inpatient hospital stays, emergency room visits, and the use of GI-related 
testing and procedures and any medications prescribed to treat Rome IV diagnoses. 
A003: Reference: Where FGID screening module, patient facing questionnaire is 
"Gastrointestinal (GI) Symptom Survey". Where tool usability questionnaire, patient 
facing questionnaire is "Gastrointestinal Symptom Survey Tool: Usability and 
Qualitative Data Survey" with 2 versions for age 
 
 

q23358 
Will any non-English study documents be uploaded? 
Yes 
 
q23359 
The PI affirms that translated versions are complete and accurate 
translations which do not contain information not presented within 
the context of the English version(s). 
Yes 
 
q24919 
Is this research funded by, or has a funding application been 
submitted to, a federal agency? This includes federal pass-through 
funding.  
Yes 
 
q25019 
Provide the name of the federal funding agency. 
q23234 
List inclusion criteria - eligibility criteria for subjects.  
FGID module: Any child between the ages of 0 through 18 who is a pediatric primary 
care clinic in the Eskenazi health system and the PCP/physician who sees them A002 
Tool usability questionnaire: A subset of patients who completed the FGID module 
between age 0 and 17 Survey (online and phone): A subset of patients with a positive 
screen for a FGID and their parents between age 0-17 Baseline retrospective review: 
Any patient ages 0-18 who presented to a a pediatric primary care clinic in the 
Eskenazi health system prior to the implementation of the FGID module Health care 
utilization retrospective review: Any patient ages 0-18 who presents to a pediatric 
primary care clinic in the Eskenazi health system after the implementation of the 
FGID module 
 
q23235 
List exclusion criteria (any criteria which would exclude otherwise 
acceptable subjects).  
FGID module, retrospective reviews: none A002 Tool usability questionnaire: does 
not meet inclusion for FGID module and did not complete the module Survey (online 

and phone): Parent and patient be able to provide consent/assent in English or 
Spanish. We do not currently have the resources to include participants who speak a 
language other than English and Spanish. 
 
q23346 
Will subjects be paid for their participation in the study? Payment 
includes reimbursement of expenses (other than compensation for 
injury). 
Yes 
 
q23347b 
Describe the payment arrangement, including amount and timing of 
disbursement.  
FGID module, retrospective reviews: none (no patient interaction) Survey 
participation (online and phone): Patients and parents/legal guardians will receive a 
$25 gift card for completing enrollment and the 1 mo survey. They will receive a $10 
gift card for each phone survey they complete thereafter. Requested timepoints are 
3, 6, and 12 months. For those that complete all time points, they will receive a $20 
bonus after completing the 12 month phone survey. All gift cards will be sent 
electronically unless a physical card is requested by the participant. In those 
circumstances, the study team will work to make an accommodations where can. 
A002 Tool usability questionnaire: Patients will receive a $20 e gift card for after 
completing the survey 
 
q23348 
Justify the proposed payment arrangement described above, 
specifically why payment does not provide undue influence for subject 
participation. 
Survey participation (online and phone): We do not believe that the payments 
described above provide undue influence because the time requested. Time required 
to enroll is approx. 20 minutes and each phone call approx. 10 minutes. A002 Tool 
usability questionnaire: Participation is voluntary. Payment of $20 is a thank you for 
the time dedicated to completing the questions. This is a minimal risk study and the 
amount offered should not coerce or create undue influence to participate. 
 
 
 

q23349 
Will partial payment be provided if the subject withdraws prior to 
completion of the study? 
No 
q23350 
Explain why failure to offer partial payment will not unduly influence 
subjects to complete the study. 
Survey participation (online and phone): Each data collection point will offer a 
payment so even participants who chose to withdraw will receive payment for their 
time. A002 Tool usability questionnaire: Only completed surveys will be 
compensated. If the participant feels uncomfortable answering questions or for 
other reason chooses not to complete the questionnaires, compensation at this level 
should not unduly influence subject to proceed. 
 
q23352 
Does this research involve (choose all that apply):  
• the STUDY of any of the following products (regardless of FDA approval status). 
“The study of” means at least one objective of the study is related to obtaining 
data about the product 
• USE of any of the following products which have not been cleared or approved 
by the FDA for use in the US 
• USE of any of the following products for open label extension, treatment, or 
compassionate use 
NONE 
 
q23454a 
This research involves (check all that apply): 
None of the Above 
 
q25049a 
Is this research considered a prospective clinical study? 
Yes - This study may require entry in OnCore. 
 
 
 

q30000a 
Is this community-engaged research? 
No 
C-Sites and Collaborations 
q700 
Are there additional locations of research, not already listed? 
No 
q704 
Are you requesting that IU provide IRB approval for any researchers 
who are NOT IU affiliates? 
No 
q710a 
 Is this a multi-center study or multi-site clinical trial? 
No 
 
D-Recruitment Methods 
q23236 
Describe how potential subjects will be initially identified.  
Potential subjects will be identified via the following: FGID module: child age 0 
through 18 year old who is patient of a pediatric primary care clinic in the Eskenazi 
health system via age/DOB and all physicians at these clinics A002 Tool usability 
questionnaire: patient completed FGID module, age 0-17 years Survey (online and 
phone): patients with a positive FGID screen per the module, age 0-17 years Baseline 
retrospective review: query of RMRS for FGID diagnoses in pediatric primary care 
clinic in the Eskenazi health system Health care utilization retrospective review: 
patients with a positive FGID screen via the module 
 
q30002 
Check any of the following sources of information which will be used 
to identify potential subjects.  
Medical records or clinic schedules 
 
q30003 
Describe how potential subjects will be initially contacted. 
FGID module, retrospective/prospective reviews: There is no contact with subjects 
for this part of the study as it is retrospective and prospective data review. Before 

the FGID module launches in clinic, physicians at both control and intervention clinics 
will be informed about the module and its respective functions. Phone survey: Study 
staff will contact parents and patients via phone and will use the verbal script 
(included in survey) to present the study to the potential subject. If phone attempt is 
unsuccessful, RA may send a follow up email if they deem this to be beneficial and 
not intrusive. Email script in Notes and Attachments. Expanded recruitment option 
for phone surveys: For patients who completed a FGID screening module with a 
positive result, patients may receive a MyChart message that will introduce this 
study opportunity prior to receiving a call from study team. A012: The MyChart 
message will include the option for online enrollment for English speakers (phase 1). 
The MyChart message for patients with Spanish as the preferred language, will 
remain unchanged from A011. The online enrollment option will be added for 
Spanish speakers in a later amendment (phase 2). A002 Tool usability questionnaire: 
After the parent, parent/ patient dyad, or patient has completed the FGID module, 
they will receive electronic communication [via EPIC MyChart (preferred) or email] 
on behalf of the study team offering the opportunity to provide voluntary feedback. 
 
q23237 
Check any of the following recruitment materials which will be used to 
contact potential subjects.  
Direct Mail/Email 
Verbal Scripts 
Other 
 
q23237C7Text 
Explain the Other recruitment material(s) which will be used to 
contact potential subjects. 
EPIC MyChart 
 
q25426b 
Select any of the following circumstances which apply to this research. 
None of the above. 
 
q23245 
Would participation in this study preclude subjects from participating 
in other research studies?  
No 

 
E-Risks Benefits Protections 
q23296 
List and describe (in lay terms) the potential risks to which subjects 
may be exposed as a result of their participation in the research. 
FGID module, retrospective/prospective reviews: minimal risk of loss of 
confidentiality A002 Tool usability questionnaire: As with phone surveys, minimal 
risk of loss of confidentiality and possible discomfort answering questions Survey 
(online and phone): minimal risk of loss of confidentiality and possible discomfort 
answering questions 
 
q23297 
Describe procedures for protecting against, or minimizing, the 
potential risks listed above. Include any procedures that are already 
being performed on subjects for diagnostic, treatment, or standard 
purposes. 
All procedures: Study team personnel have been trained in human subjects’ research 
practices and HIPAA regulations (i.e. confidentiality, privacy and security practices). 
Furthermore, all data will be securely transferred and stored on fire-walled, 
encrypted and password-protected hard drives and databases, and locked file 
cabinets will be used to store any confidential paper study materials. Tool Usability 
Questionnaire: If participants do not feel comfortable completing the questionnaire 
they have the right to discontinue their participation right and end the session. 
 
q23299 
Explain how research data will be protected so that only approved 
persons have access to subjects’ identifiable data (i.e. confidentiality 
of data). 
FGID module: The EPIC system runs on a server in the Eskenazi Health network. This 
server resides behind the Eskenazi firewall and is accessible only to Eskenazi IT staff. 
Study data pulls are handled by faculty and staff with appropriate IRB approvals and 
HIPAA compliance training. Identifiable data is secured in transit via SSL encryption 
or via encrypted files in the case of data pulls for data analysis.  A002 Tool usability 
questionnaire: Responses will be securely stored in a REDCap database with access 
limited to the study team members. Survey(online and phone): All survey data will 
be securely stored in a REDCap database with access limited to the study team 
members. Baseline retrospective review: All data will be securely access, transferred, 

and stored for analysis and only accessible to members of the study team. Health 
care utilization retrospective review: see above 
 
q23300 
Explain how subjects’ physical privacy will be protected, both during 
recruitment/screening and during participation in the research. 
FGID module, retrospective/prospective reviews: There is no contact with patients 
for this portion of the study; this is a retrospective and prospective review of data. 
Physicians will document any FGID assessments/plans in an environment deemed 
appropriate by the provider to document usual clinical care. Survey(online and 
phone): Phone: The verbal consent, authorization, assent (if applicable) and surveys 
will take place with study personnel completing the procedures in a private space. 
Online: The questionnaire will be completed in a space deemed appropriate by the 
participant who is filling out the questionnaire independently. A002 Tool usability 
questionnaire: The questionnaire will be completed in a space deemed appropriate 
by the participant who is filling out the questionnaire independently. 
 
q23301 
Is there a potential for subjects to benefit directly from participation in 
the study? 
Yes 
 
q23302 
Describe the potential benefits to be gained by the individual 
SUBJECT. Please note that payment for participation is not considered 
a benefit.   
FGID module, retrospective/prospective reviews: There are no potential benefit to 
patients for being part of a data review. Physicians at intervention clinics may benefit 
from knowledge gained via the automated guidance for diagnosing and managing 
FGIDs. A002 Tool usability questionnaire: Obtaining user feedback is a means to 
ensure the tool provides optimal user experience. The user may not directly benefit 
from this encounter but may benefit from the information learned if/when they 
complete this module again in future visits to their care provider. Survey(online and 
phone): no potential benefit 
 
 
 
 

q23303 
State the potential benefits or information which may accrue to 
SCIENCE or SOCIETY in general as a result of this work. 
There is a significant benefit to society at large as the results of this research allow us 
to substantially improve the care of patients with functional GI disoders by 
standardizing health information technology-based interventions that can then be 
used in a variety of settings to accomplish transition. The lessons we learn from this 
intervention could then be used at a health system and national level. 
 
F-Data Safety Monitoring 
q23304 
Describe the provisions for monitoring the data to ensure the safety of 
subjects.   
All procedures: Oversight for the conduct of the study will be provided by the 
principal investigator. Adverse events are not anticipated, but any occurring will be 
documented and reported according to Human Research Protection Program (HRPP) 
at Indiana University policies and procedures. The PI will take primary responsibility 
for data collection and verification, and review of cumulative adverse events. Any 
cumulative adverse events and study progress summary will be communicated to the 
IRB at the time of continuing review. 
G1-Children 
q22116 
Select the category below which best applies. 
45 CFR 46.404: Research not involving greater than minimal risk to children. 
 
q23199 
Will you be enrolling foster children or children who are considered 
wards (i.e. who have been placed in the legal custody of the State or 
other agency, institution per local, state, or federal law)? 
No 
H-Informed Consent 
q901 
Will all or some subjects consent to participate in the research? 
Some subjects (or their legally authorized representative) will consent to participate 
in the research, and some subjects will not. 
 

q902 
Explain which subjects will consent to the research, and which subjects 
will not.   
FGID module, retrospective/prospective reviews: No consent will be obtained for 
using the prospective and retrospective data reviews. A002 Tool usability 
questionnaire: If the individual agrees to participate by voluntarily proceeding to 
questionnaire, consent is implied. Survey(online and phone): Phone: verbal 
consent/assent will be obtained. Online: electronic signature will be obtained 
Subjects who age up to 18 while on study, whose parents will continue to answer the 
phone survey on their behalf, will not be consented. 
 
q909 
For those subjects who will consent to participate, explain how 
subjects (or subjects’ legally authorized representative) will be 
presented with the information needed to decide to participate, 
including all elements of informed consent.   
Survey(online and phone): Phone: The RA will verbally review the Study Information 
Sheet/Auth over the phone with the parent/legal guardian and, when appropriate, 
with the patient, and answer any questions before obtaining verbal consent from the 
parent for both his/her own parental participation as well as the participation of the 
minor/patient. A copy of the study SIS/Auth will be sent to participants done 
electronically where able after receiving consent to send email to the participant. 
Online: A MyChart message will be sent to the patient/patient proxy to introduce the 
study opportunity. This introduction will include the SIS/Auth. The English version 
will include a time limited participant specific link to the REDCap e-consent. (Patient 
communication uploaded in Notes and Attachments). Recognizing that the MyChart 
account for patients 14-17 may not have a parent proxy assigned, a statement is 
added to the introduction requesting interested teens share this study information 
with a parent/legal guardian for full consideration and consent. A002 Tool usability 
questionnaire: After the parent, parent/ patient dyad, or patient (add A003 "or 
patient") has completed the FGID module, they will receive communication offering 
opportunity to provide voluntary feedback. If interested in providing feedback, they 
will be presented with the electronic SIS (in Notes and Attachments) for them to read 
independently. 
 
 
 
 

q903 
Describe any informed consent tools which will be used to present 
information to potential subjects (i.e. consent documents, videos, 
brochure, drug/device information, etc) and how they will be used.  
Survey(online and phone): SIS/Auth form A002 Tool usability questionnaire: SIS 
 
q925 
Describe the timing of the informed consent process, including how 
you will ensure potential subjects have sufficient opportunity to 
discuss and consider participation before agreeing to participate in the 
research. 
Survey(online and phone): Phone: The informed consent process for phone surveys 
will take place over the phone when the patient and parent indicate their interest 
and availability. Any participants wishing more time to consider will be called back at 
a different time. Online: After reviewing the MyChart recruitment message, the 
potential participant will be able to advance directly to the online enrollment process 
when they desire. A002 Tool usability questionnaire: After the parent, parent/ 
patient dyad, or patient has completed the FGID module, expressed interest in 
providing feedback, read the SIS, and implied consent by voluntarily proceeding to 
the questionnaire. 
q30127a 
Will you include all required elements of consent in your consent 
process?   
Yes 
 
q921 
Indicate in what language(s) the consent conversation will be 
conducted. 
English 
 
q926 
Explain how you will ensure potential subjects understand the 
information you have presented to them before they agree to 
participate in the study.  
Survey(online and phone): Phone: An RA will ask participants if they have any 
questions (and provide the answers to those questions) before the subject agrees to 

participate. Online: The e-consent instrument will contain instructions for 
completion. Within those instructions will be PResNet contact information for 
questions. If participants proceed without asking questions, it is implied that the 
content was understood. A002 Tool usability questionnaire: Participants will 
voluntarily agree to fill out questionnaire before being presented with the survey. If 
they do not understand the content or choose not to participate, they are given the 
option to decline participation. 
 
q929 
Briefly describe any training provided to investigators who are 
obtaining informed consent.   
Phone surveys: PResNet Research Assistants have been trained in obtaining informed 
consent (and assent) through online CITI training, university-sponsored training, and 
internal training and QA programs. 
 
q931 
Does the research include any minimal risk procedures to which 
subjects will not consent?   
Yes 
 
q932 
A waiver of consent for those procedures is required. List the 
procedures and explain how they involve no more than minimal risk to 
the subject. 
FGID module, retrospective/prospective reviews: We are requesting a waiver of 
consent for this part of the research. Patients and parents will be asked (but not 
required) to respond to yes/no questions about GI symptoms as part of standard 
care. No part of this research presents more than a minimal risk to subjects. Study 
team personnel have been trained in human subjects’ research practices and HIPAA 
regulations (i.e. confidentiality, privacy and security practices). Furthermore, all data 
will be securely transferred and stored on fire-walled, encrypted and password-
protected hard drives and databases, and locked file cabinets will be used to store 
any confidential paper study materials. 
 
q933 
Explain how the waiver will not adversely affect the rights and welfare 
of subjects. 

FGID module, retrospective/prospective reviews: The waiver will not adversely affect 
the rights and welfare of subjects as we are only (securely) accessing and using data 
generated in a clinical setting under standard care. 
 
q905 
Explain how the research could not be practicably carried out if 
informed consent were required. 
FGID module, retrospective/prospective reviews: If informed consent were required, 
we could not practicably obtain consent from the patients who answer module 
questions or whose data is used in the retrospective reviews as there are no study 
staff present in clinics. 
 
q30004b 
Explain why the research could not be practicably carried out without 
identifiers. 
FGID module, retrospective/prospective reviews: Without identifiers, we could not 
conduct the research because we need to link patient encounter data to past and 
prospective health data to look at patient outcomes. 
 
q914 
Explain how subjects will be informed of pertinent results at the 
conclusion of the study, if appropriate. If subjects will not be 
informed, enter N/A.   
N/A 
q23678a 
For those subjects who will consent to participate, choose whether the 
consent process will be documented by a written signature from 
subjects. 
Some subjects will provide a written signature as documentation of consent, and 
some subjects will not. 
 
q30129a 
Will subjects participate in any study activity prior to physically signing 
a consent document? 
No 
 

q939a 
Explain which subjects will provide a written signature as 
documentation of consent, and which subjects will not.   
Survey participants who enroll online will be asked for a printed (typed) signature.  
 
q940b 
Explain the process for obtaining a written signature from subjects.  
Using the REDCap e consent platform parents/guardians will type their name in a 
signature box 
 
q934a 
Since some subjects will not provide a written signature as 
documentation of consent, a waiver of documentation of consent is 
required. Choose the option which most appropriately applies to your 
study.    
The research presents no more than minimal risk of harm to subjects AND involves 
no procedures for which written consent is normally required outside of the research 
context. 
q23764 
Since some subjects will not consent to participation in the research, a 
waiver of consent is required. Choose the appropriate reason for 
waiving consent.   
Research is minimal risk and obtaining consent is not practicable. 
 
q904b 
Explain how the research involves no more than minimal risk to the 
subjects. 
FGID module, retrospective/prospective reviews: No part of this research presents 
more than a minimal risk to subjects. Study team personnel have been trained in 
human subjects’ research practices and HIPAA regulations (i.e. confidentiality, 
privacy and security practices). Furthermore, all data will be securely transferred and 
stored on fire-walled, encrypted and password-protected hard drives and databases, 
and locked file cabinets will be used to store any confidential paper study materials. 
Survey(online and phone): : N/A - Parents and older patients will verbally or 
electronically consent (for those who agree to receive emails) to participate. A002 
Tool usability questionnaire: There is a minimal risk for loss of confidentiality. The 

questions capture information about the user's interaction with the module. A005, 
regarding new waiver for child subjects who age up while on the study: The study 
activity will remain unchanged. Patients and/or parent will continue to answer of 
short phone surveys at defined timepoints. 
 
q906b 
Explain how the waiver will not adversely affect the rights and welfare 
of subjects. 
FGID module, retrospective/prospective reviews: The waiver will not adversely affect 
the rights and welfare of subjects as we are only (securely) accessing and using data 
generated in a clinical setting under standard care. A005, regarding new waiver for 
child subjects who age up while on the study: The study activity will remain 
unchanged and is minimal risk. Patients and/or parent will continue to answer of 
short phone surveys at defined timepoints. Participants can opt to withdraw from 
study at any time. 
 
q907b 
Explain how the research could not be practicably carried out if 
informed consent were required. 
FGID module, retrospective/prospective reviews: If informed consent were required, 
we could not practicably obtain consent from the patients who answer module 
questions or whose data is used in the retrospective reviews as there are no study 
staff present in clinics. A005, regarding new waiver for child subjects who age up 
while on the study: Intent is to limit any barriers to ongoing participation. In the 
event that the parent has been the main source of information for the phone surveys 
(for teen age 17), we wanted to minimize any disruptions. 
 
q30004d 
Explain why the research could not be practicably carried out without 
identifiers. 
FGID module, retrospective/prospective reviews: Without identifiers, we could not 
conduct the research because we need to link patient encounter data to past and 
prospective health data to look at patient outcomes. Survey(online and phone): The 
research could not be practicably carried out without identifiers because we are 
contacting patients who screened positive in clinic. A002 Tool usability 
questionnaire: The research could not be practicably carried out without identifiers 
because we are only surveying family who have completed the module and meet our 
inclusion age and setting 

q908b 
Explain how subjects will be informed of pertinent results at the 
conclusion of the study, if appropriate. If subjects will not be 
informed, enter N/A.   
N/A 
J-Child Assent Parent Consent 
q23808 
Can children provide legal consent for themselves to participate in this 
study? 
No children can provide legal consent for themselves. 
 
q936 
Will consent be obtained from subjects’ parents/guardians? Select 
both options if consent will be obtained from some parents but not all. 
Yes 
No. I am requesting a waiver of parental consent. 
 
q23779 
Explain how parents/guardians will be presented with the information 
needed to decide to allow their children to participate, including all 
elements of informed consent.  
FGID module, retrospective/prospective reviews: N/A - We will not obtain parental 
consent for the inclusion of their children's data in the data reviews. We are seeking 
a waiver of parental consent for this portion of the research. A002 Tool usability 
questionnaire: The potential participant will have no interaction with a research 
team member at the point the questionnaire opportunity is introduced. We will 
inform prospective subjects about the research opportunity via a SIS. It is not 
practical to obtain signed consent. If the individual agrees to participate by 
voluntarily proceeding to questionnaire, consent is implied. A003 Tool usability 
questionnaire:The 14-17 year old will assent for self, parental consent deemed not 
feasible and waiver parental consent requested for this age group. For patients 14-
17year old, the parent has limited permissions to access the patient"s MyChart 
account. This age group will complete the FGID module independently or with assist 
if they choose. We request a waiver of parental consent since the 14-17 year old has 
their own account and thus getting parental consent is not feasible. Survey(online 
and phone): Phone: For the phone surveys, we will seek verbal consent from the 
parent for the child's participation. The RA will verbally review the SIS/Auth form 

over the phone and answer any questions before obtaining verbal consent and auth 
from the parent the participation of the minor/patient if age 10-17 years old. Online: 
A MyChart message will be sent to the patient/patient proxy to introduce the study 
opportunity. This introduction will include the SIS/Auth and a time limited 
participant specific link to the REDCap e-consent. (Patient communication uploaded 
in Notes and Attachments). Recognizing that the MyChart account for patients 14-17 
may not have a parent proxy assigned, a statement is added to the introduction 
requesting interested teens share this study information with a parent/legal 
guardian for consideration and consent.  
 
q23780 
Describe any informed consent tools which will be used to present 
information (i.e. consent documents, videos, brochure, drug/device 
information, etc) and how they will be used.  
FGID module, retrospective/prospective reviews: N/A Survey(online and phone): 
SIS/Auth form A002 Tool usability questionnaire: Study Information Sheet 
 
q23784 
Describe the timing of the informed consent process, including how 
you will ensure parents/guardians have sufficient opportunity to 
discuss and consider their children’s participation before agreeing to 
allow their children to participate in the research. 
FGID module, retrospective/prospective reviews: N/A Survey(online and phone): 
Phone: The informed consent process for phone surveys will take place over the 
phone when the patient and parent indicate their interest and availability. Any 
participants wishing more time to consider will be called back at a different time. 
Online: After reviewing the MyChart recruitment message, the potential participant 
will be able to advance directly to the online enrollment process when they desire. 
A002 Tool usability questionnaire: After the parent, parent/patient dyad, or patient 
(add A003 "or patient") has completed the FGID module, expressed interest in 
providing feedback, read the SIS, and implied consent by voluntarily proceeding to 
the questionnaire. 
 
q30127c 
Will you include all required elements of consent in your consent 
process?  
Yes 

q23789 
Indicate in what language(s) the consent conversation will be 
conducted. 
English 
 
q23793 
Explain how you will ensure parents/guardians understand the 
information you have presented to them before they agree to allow 
their children to participate in the research.  
FGID module, retrospective/prospective reviews: N/A Survey(online and phone): 
Phone: An RA will ask participants if they have any questions (and provide the 
answers to those questions) before the subject agrees to participate. Online: The e-
consent instrument will contain instructions for completion. Within those 
instructions will be PResNet contact information for questions. If participants 
proceed without asking questions, it is implied that the content was understood. 
A002 Tool usability questionnaire: Participants will voluntarily agree to fill out 
questionnaire before being presented with the survey. If they do not understand the 
content or choose not to participate, they are given the option to decline 
participation. 
 
q23798 
Briefly describe any training provided to investigators who are 
obtaining informed consent.   
Phone surveys: Research Assistants have been trained in obtaining informed consent 
(and assent) through online CITI training, university-sponsored training, and internal 
training and QA programs. 
 
q23800 
Does the research include any minimal risk procedures to which 
parents/guardians will not consent for their children to participate?   
No 
 
q30330 
For those parents/guardians who will consent to allow their children 
to participate, choose whether the consent process will be 
documented by a written signature. 

Some parents/guardians will provide a written signature as documentation of 
consent, and some will not. 
 
q30331 
Will subjects participate in any study activity prior to 
parents/guardians physically signing a consent document? 
No 
 
q30334 
Explain which parents/guardians will provide written signature as 
documentation of consent, and which will not. 
Survey participants who enroll online will be asked for a printed (typed) signature.  
 
q30333b 
Explain the process for obtaining a written signature from 
parents/guardians. 
Using the REDCap e consent platform parents/guardians will type their name in a 
signature box 
 
q30335 
Since some parents/guardians will not provide a written signature as 
documentation of consent, a waiver of documentation of 
parental/guardian consent is required. Choose the option which most 
appropriately applies to your study.   
The research presents no more than minimal risk of harm to subjects AND involves 
no procedures for which written consent is normally required outside of the research 
q942 
Choose the option which most appropriately applies to your study.    
Parental/guardian consent cannot be practicably obtained. 
 
q943 
Explain how the research involves no more than minimal risk to the 
subject.  
FGID module, retrospective/prospective reviews: For the data reviews, parental 
consent cannot be practicably obtained as there are no study staff in clinic and 
attempting to reach each parents of so many patients is not feasible. There is a 

minimal risk for loss of confidentiality but not beyond the risk of a routine clinic visit. 
No part of this research presents more than a minimal risk to subjects. Study team 
personnel have been trained in human subjects’ research practices and HIPAA 
regulations (i.e. confidentiality, privacy and security practices). Furthermore, all data 
will be securely transferred and stored on fire-walled, encrypted and password-
protected hard drives and databases, and locked file cabinets will be used to store 
any confidential paper study materials. 
 
q944 
Explain how the waiver will not adversely affect the rights and welfare 
of subjects. 
FGID module, retrospective/prospective data reviews: There is a minimal risk for loss 
of confidentiality but not beyond the risk of a routine clinic visit. The subjects will 
continue to receive care as normal, waiver will not affect care provided. No part of 
this research presents more than a minimal risk to subjects. Study team personnel 
have been trained in human subjects’ research practices and HIPAA regulations (i.e. 
confidentiality, privacy and security practices). Furthermore, all data will be securely 
transferred and stored on fire-walled, encrypted and password-protected hard drives 
and databases, and locked file cabinets will be used to store any confidential paper 
study materials. 
 
q945 
Explain how the research could not be practicably carried out if 
informed consent were required. 
FGID module, retrospective/prospective reviews: The research could not be 
practicably carried out if informed consent of patients at clinic visits were required 
because there are no study staff on site to conduct the consent process. (Research 
staff are not based in the study clinics.) Additionally, informing patients that they are 
part of a study involving GI disorders may bias the results given to the clinician, and 
in turn, to the FGID module. 
 
q30004i 
Explain why the research could not be practicably carried out without 
identifiers. 
FGID module: The research could not be practicably carried out without identifiers 
because GI screening questions are based on patient DOB/age. Survey(online and 
phone): The research could not be practicably carried out without identifiers because 
we are contacting patients who screened positive in clinic. A002 Tool usability 

questionnaire: The research could not be practicably carried out without identifiers 
because we are only surveying family who have completed the module and meet our 
inclusion age and setting 
 
q946 
Explain how subjects will be informed of pertinent results at the 
conclusion of the study, if appropriate. If subjects will not be 
informed, enter N/A.   
N/A 
q950 
In order to describe the process for obtaining assent from children, 
check all that apply. 
Some/all children are not capable of providing assent. 
Some/all children will not provide assent even though they are otherwise capable. A 
waiver of assent will be requested. 
Some/all children will provide assent. 
 
q951 
Explain why children are not capable of providing assent. Consider 
age, maturity, and psychological state, and situations where capability 
is so limited that they cannot reasonably be consulted.  
This research will include patients ages 0 through 17 and children age 0-6 are 
typically not considered mature enough to provide assent. 
 
q952 
Choose the option which most appropriately applies to your study.    
Assent cannot be practicably obtained. 
 
q953 
Explain how the research involves no more than minimal risk to the 
subject.  
FGID module: In clinic, patients and parents will be asked (but not required) to 
respond to yes/no questions about GI symptoms as part of standard care. There is a 
minimal risk for loss of confidentiality but not beyond the risk of a routine clinic visit. 
Phone surveys: N/A - will get verbal assent from older patients Retrospective 
reviews: There is only a minimal risk of loss of confidentiality as all data will be 

securely accessed, transferred, and analyzed. A002 Tool usability questionnaire: 
There is a minimal risk for loss of confidentiality. The questions capture information 
about the user's interaction with the module. 
 
q954 
Explain how the waiver will not adversely affect the rights and welfare 
of subjects. 
FGID module, retrospective/prospective reviews:There is a minimal risk for loss of 
confidentiality for the retrospective and prospective review of data but not beyond 
the risk of a routine clinic visit. Phone surveys: N/A (verbal consent/assent) A002 
Tool usability questionnaire: Consent implied through agreement to participate 
 
q955 
Explain how the research could not be practicably carried out if child 
assent were required. 
FGID module, retrospective/prospective reviews:: The research could not be 
practicably carried out if informed assent of patients at clinic visits were required 
because there are no study staff on site to conduct the consent process. (Research 
staff are not based in the study clinics.) Additionally, informing patients that they are 
part of a study involving GI disorders may bias the results given to the clinician, and 
in turn, to CHICA. Phone survey: N/A (verbal consent/assent) A002 Tool usability 
questionnaire: The parent, parent/child dyad, or patient (add A003 "or patient") who 
filled out the tool will be presented with the SIS. The SIS will serve as a consent and 
assent tool, the questionnaire is targeted to the individual or individuals who 
completed the module. 
 
q30004j 
Explain why the research could not be practicably carried out without 
identifiers. 
FGID module, retrospective/prospective reviews:: The research could not be 
practicably carried out without identifiers because GI screening questions and are 
based on patient DOB/age. Retrospective reviews are based on patient DOB, 
symptoms, and diagnoses. Phone survey: The research could not be practicably 
carried out without identifiers because we are contacting patients who screened 
positive in clinic. A002 Tool usability questionnaire: The research could not be 
practicably carried out without identifiers because we are only surveying family who 
have completed the module and meet our inclusion age and setting 
 

q956 
Explain how subjects will be informed of pertinent results at the 
conclusion of the study, if appropriate. If subjects will not be 
informed, enter N/A.   
N/A 
q958 
Describe the timing of the assent process, including how you will 
ensure children have sufficient opportunity to discuss and consider 
participation before agreeing to participate in the research. 
Surveys Phone enrollment: After getting permission from the parent/LG to speak 
with the patient ages 10 through 17, the RA will verbally review the SIS/Auth with 
the youth at the same time it is reviewed with the parent, answer any questions, and 
call back later if s/he would like more time to consider participation. Online 
enrollment: In a brief introduction to the online consent process on the E-consent 
page, it is asked that the child age 10 and older review the online consent document 
with the parent. During the recruitment phone contact or online enrollment: If the 
parent has the desire to complete enrollment and the youth is unavailable, 
enrollment will proceed without assent to decrease burden on family and barrier to 
enrollment. A002 Tool usability questionnaire: After the parent, parent/patient dyad, 
or patient (add A003 "or patient") has completed the FGID module, they will receive 
communication offering the opportunity to provide voluntary feedback. If interested 
in providing feedback, they will be presented with the electronic SIS (in Notes and 
Attachments) 
 
q959 
Describe any assent tools which will be used to present information to 
potential subjects (i.e. assent document, study information sheet, 
videos, brochure, drug/device information, etc) and how they will be 
used.  
Phone surveys: SIS/Auth form will be used for assent of patients 10 years and older. 
Will not seek assent for child < 10. Assent tool will be used for those 10-13 and 
consent form will be used for ages 14-17. Only verbal assent will be obtained. A002 
Tool usability questionnaire: electronic SIS (in Notes and Attachments) 
 
 
 
 

q996 
Will children indicate their consent with a signature on an assent or 
consent statement? 
Subjects will not provide a signature 
K-HIPAA 
q23253 
Are you part of a covered entity (health care provider that transmits 
health information electronically) or are you receiving information 
from a covered entity as part of your research?  
Yes 
 
q23254 
Will protected health information be utilized, accessed, collected, or 
generated as part of the study? 
Yes 
 
q30347a 
Select the electronic systems to be used for the collection and/or 
storage of protected health information (ePHI). Choose all that apply. 
REDCap 
IU Box Health Data Account 
q23257 
Will you be accessing or collecting protected health information for 
RECRUITMENT purposes?   
Yes 
 
q23258 
Choose all that apply to the recruitment plans.   
Review of medical records by the study team 
 
q23259 
Will review of medical records for recruitment purposes be conducted 
by an investigator who is NOT a part of the potential subject's care 
team?  
No 

q23277 
HIPAA applies to your study, and requires that you obtain 
authorization for PARTICIPATION in research, or that you request a 
waiver. Check all that apply. 
I will obtain written, signed authorization from subjects prior to their participation 
I will obtain authorization from subjects prior to their participation but subjects will 
not physically sign a document 
I will not obtain authorization prior to their participation 
 
q23650 
List all data elements to be used or disclosed (do not refer to an 
attachment). 
FGID Module: Data points collected for participation in the retrospective review of 
FGID module data include date(s) of visit, physician name, patient vitals and 
demographics, contact information, patient/parent answers to GI questions, who is 
answering the questions (parent or patient or both), and physician notes about GI 
diagnoses, treatments, and recommendations. Phone survey: In addition to the FGID 
data points above, we will use parent and patient answers to the phone survey along 
with parent-reported demographics. Baseline retrospective review: DOB, 
date/diagnosis (ICD codes), Eskenazi clinic(s) of care Health care utilization 
retrospective review: • The presence of outpatient sick visits within the CHICA 
system clinic for any complaint • The presence of outpatient sick visits within the 
CHICA system clinic with an associated GI billing code • The presence of visits to 
statewide providers, including inpatient hospital stays, outpatient clinic visits, and 
emergency room visits. • The occurrence of any GI-related testing and procedures – 
specifically radiologic, laboratory testing,endoscopy, and surgical procedures related 
to GI diagnoses • The use of any medications prescribed to treat Rome IV diagnoses 
– specifically acid-suppressants, antispasmodics, antidepressants, stool softeners and 
laxatives, and pro-motility agents. A005, regarding child subjects who age up to 18 
while on the study, whose parents will continue to answer the phone survey on their 
behalf: Will proceed with the same data collection as prior to birthday. Will as 
before, collect responses from the FGID Module, phone survey responses and parent 
reported demographics for self (where applicable). 
 
 
 
 
 

q23651 
A waiver of the requirement for a written signature must be approved 
by the IRB. Explain how this research involves no more than minimal 
risk of loss of confidentiality to the subject.  
No part of this research presents more than a minimal risk of loss of confidentiality 
to subjects. Study team personnel have been trained in human subjects’ research 
practices and HIPAA regulations (i.e. confidentiality, privacy and security practices). 
 
q23652 
Describe the plan for protecting identifiers from improper use and 
disclosure.  
All data will be securely transferred and stored on fire-walled, encrypted and 
password-protected hard drives and databases, and locked file cabinets will be used 
to store any confidential paper study materials. 
 
q23653 
Describe the plan to destroy identifiers at the earliest opportunity 
appropriate for the research, considering the purpose of the research 
and local data retention requirements. 
We will destroy identifiers in the database (and any paper records) at the earliest 
opportunity appropriate for the research and allowable by law. 
 
q23654 
Confirm that the study team will assure identifiable PHI will not be re-
used or disclosed to individuals outside the study team, except as 
required by law.  
PHI will not be re-used or disclosed to individuals outside the study team, except as 
required by law. 
 
q23655 
Explain how the research could not be practicably conducted without 
waiver of authorization or alteration of authorization requirements.  
The research could not be practicably carried out if authorization for the use of PHI 
were required because there are no study staff on site to conduct the informed 
authorization process. (Research staff are not based in the study clinics.) Regarding 
new waiver for child subjects who age up while on the study: Intent is to limit any 

barriers to ongoing participation. In the event that the parent has been the main 
source of information for the phone surveys (for teen age 17), we wanted to 
minimize any disruptions. 
 
q23656 
Explain how the research could not be practicably conducted without 
access to and use of identifiable PHI.  
The research could not be practicably conducted without access to PHI because we 
are identifying patients based on health information (FGIDs) and their connecting 
data across sources. 
q23278 
Will you be collecting information from subjects’ medical records? 
Yes, I have uploaded an Authorization template to the Attachments section. 
 
q23693 
Explain which subjects will sign a written authorization form and which 
subjects will not. 
Surveys Phone enrollment: Parents will provide verbal authorization for use of their 
child's PHI via phone. (No one will provide written/signed authorization.) Online 
enrollment: Parents will provide electronic signature on the the REDCap E-consent to 
document consent and authorization to participate 
 
q23694 
Explain how the elements of authorization will be presented to 
potential subjects, including a description of any tools used.  
The elements of authorization will be presented to parents via phone by review of 
the Authorization form. (Parents may also choose to receive a copy via mail with 
their gift card.) 
Attachments 
Attachment Type 
Data Collection Instrument 
Attachment 
FGID Algorithm Tool Usability and Qualitative Survey - Ages 0-13 - with SUS and 
demographics_4.9.20 MF.docx 
Name 
Gastrointestinal Symptom Survey Tool – Usability and Qualitative Data Survey Ages 0 
to 13 Years 

Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FGID Algorithm Tool Usability and Qualitative Survey - Ages 14-17 - with SUS and 
demographics_4.9.20 MF.docx 
Name 
Gastrointestinal Symptom Survey Tool – Usability and Qualitative Data Survey Ages 
14 to 17 Years 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpFunctionalDyspepsiaEpi.pdf 
Name 
Functional Dyspepsia- Epigastric Pain Syndrome Subtype 8yr to 18 yr Phone Survey 
Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpIrritableBowelSyndrome.pdf 
Name 
Irritable Bowel Syndrome 8yr to 18 yr Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpAbdominalPainOtherwise.pdf 
Name 
Abdominal Pain-Otherwise not specified 8yr to 18 yr Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpAbdominalMigraine8yrTo.pdf 
Name 

Abdominal Migraine 8yr to 18 yr Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpInfantRegurgitation012-2.pdf 
Name 
Infant Regurgitation 0-12mo Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpInfantColic06mo_System.pdf 
Name 
Infant Colic 0-6mo Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpInfantDyschezia012mont.pdf 
Name 
Infant Dyschezia 0-12months Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpAerophagiaAllAges0mo18.pdf 
Name 
Aerophagia all ages 0mo-18yrs Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpInfantRuminationSyndro.pdf 
Name 
Infant Rumination Syndrome 0-12mo Phone Survey Draft 
Comments 

Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpRumination4yrsTo18yrs_.pdf 
Name 
Rumination 4yrs to 18yrs 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpFunctionalConstipation.pdf 
Name 
Funct Constipation 0-12 mo Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpFunctionalConstipation.pdf 
Name 
Funct Constipation 12 mo to 18yrs Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpCyclicVomitingSyndrome-2.pdf 
Name 
Cyclic Vomiting Syn 0-18yrs Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpFunctionalDiarrhea6moT.pdf 
Name 
Functional Diarrhea 6mo to 8 yrs Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 

Attachment 
FollowUpNonRetentiveFecalIncon.pdf 
Name 
Non Retentive Fecal Incontinence 4yr to 18 yr Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpFunctionalVomiting8yrT.pdf 
Name 
Functional Vomiting 8yr to 18 yr Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpFunctionalNausea8yrTo1.pdf 
Name 
Functional Nausea 8yr to 18 yr Phone Survey Draft 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
FollowUpFunctionalDyspepsiaPos.pdf 
Name 
Functional Dyspepsia- Postprandial Distress Subtype 8yr to 18 yr Phone Survey Draft 
Comments 
Attachment Type 
Other 
Attachment 
MyChart%20Msg_FGID%20module%20pilot_6.11.20.docx 
Name 
MyChart script (for batch messaging) to patient introduce FGID module for pilot 
testing 
Comments 
Attachment Type 
Recruitment Materials 
Attachment 

SIS Usability Questionnaire _recruitment Intro_4.17.20.docx 
Name 
Introduction to SIS For Tool Usability Survey (questionnaire) 
Comments 
A002: Version 1.27.20 A003:4.17.20 Draft of email communication to introduce SIS 
for tool usability questionnaire. 
Attachment Type 
Recruitment Materials 
Attachment 
A012_MyChart Intro to Phone Surveys.docx 
Name 
Phone Survey Recruitment: MyChart Introduction 
Comments 
A012 replaced A008 version  
Attachment Type 
Recruitment Materials 
Attachment 
A014_Verbal Intro _Phone Contact_Parent_Patient.docx 
Name 
Phone Surveys PResNet Intro Script 
Comments 
Replaces: A011_Verbal Intro _Phone Contact_Parent_Patient.docx 
Attachment Type 
Study Information Sheet 
Attachment 
1811325201A002_SIS Usability survey__4.17.20 .docx 
Name 
SIS for Tool Usability Survey 
Comments 
A002: Version 1.27.20 A003: Version 4.17.20 
Attachment Type 
Study Information Sheet 
Attachment 
1811325201A014 - Bennett, W - SIS and Auth Phone or Online Survey - Oct 
2023.docx 
Name 
Phone Survey SIS  

Comments 
A011: Version 2.15.23 A012: Version 5.30.23 A013: Version 7.18.2023 
Attachment Type 
Recruitment Materials 
Attachment 
A011_Email Script_Phone Survey Recruitment.docx 
Name 
Comments 
A014: Cease use of this document. With updated requirements, will not send email 
communication to potential participants without attaining their consent to send. 
Attachment Type 
Recruitment Materials 
Attachment 
A012.1_MyChart Intro to Phone Surveys-1_Spanish rev.docx 
Name 
Comments 
replaced A008 version 
Attachment Type 
Recruitment Materials 
Attachment 
A014_Verbal Intro _Phone Contact_Parent_Patient_Spanish rev.docx 
Name 
Comments 
Replaces: A011_Verbal Intro _Phone Contact_Parent_Patient_Spanish rev.docx 
Attachment Type 
Study Information Sheet 
Attachment 
1811325201A014- Bennett, W - SIS and Auth Phone Survey - Oct 2023_Spanish rev-
2.docx 
Name 
Phone Survey SIS - Spanish 
Comments 
Attachment Type 
Recruitment Materials 
Attachment 
A011_Email Script_Phone Survey Recruitment_Spanish rev.docx 
Name 

Comments 
A014: Cease use of this document. With updated requirements, will not send email 
communication to potential participants without attaining their consent to send. 
Attachment Type 
Other 
Attachment 
A015- Draft E-Consent.docx 
Name 
Comments 
New: For the online enrollment of survey participants. Same language as SIS/Auth 
placed in RC E-consent framework. A015 replaced A013. 
Attachment Type 
Other 
Attachment 
A014 _RA phone script re communicating with Research Participants by Email.docx 
Name 
Comments 
A014: Script for RA to discuss email communication with existing participants 
Attachment Type 
Data Collection Instrument 
Attachment 
Demographics RC Draft.docx 
Name 
Comments 
Attachment Type 
Data Collection Instrument 
Attachment 
Payment language RC Draft.docx 
Name 
Comments 
language added to the end of follow up questionnaires completed online  
End of Protocol Form 
 
KC IRB History 
approvalDate 
December 5, 2018 

FOR HSO OFFICE USE ONLY 
Action History 
Description 
Expedited Approval 
Date 
December 18, 2020 
Action Date 
December 18, 2020 
Comments 
Amendment-005: Approved 
Updated By 
kwcrain 
Update Time 
2020-12-18T12:00:00.000Z 
Description 
Assigned to Agenda 
Date 
December 18, 2020 
Action Date 
December 18, 2020 
Comments 
Amendment-005:  
Updated By 
kwcrain 
Update Time 
2020-12-18T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
December 17, 2020 
Action Date 
December 17, 2020 
Comments 
Amendment-005: Submitted to IRB 
Updated By 
ashlmeye 
Update Time 

2020-12-17T12:00:00.000Z 
Description 
Returned To PI 
Date 
December 17, 2020 
Action Date 
December 17, 2020 
Comments 
Amendment-005: Open to revise Amendment QU and KC QUs. 
Updated By 
ashlmeye 
Update Time 
2020-12-17T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
December 16, 2020 
Action Date 
December 16, 2020 
Comments 
Amendment-005: Submitted to IRB 
Updated By 
ashlmeye 
Update Time 
2020-12-16T12:00:00.000Z 
Description 
Returned To PI 
Date 
December 16, 2020 
Action Date 
December 16, 2020 
Comments 
Amendment-005: Open to upload final versions of study documents to notes and 
attachments. 
Updated By 
ashlmeye 
Update Time 

2020-12-16T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
December 11, 2020 
Action Date 
December 11, 2020 
Comments 
Amendment-005: Submitted to IRB 
Updated By 
stasulli 
Update Time 
2020-12-11T12:00:00.000Z 
Description 
Returned To PI 
Date 
December 10, 2020 
Action Date 
December 10, 2020 
Comments 
Amendment-005: Open to edit Amendment and KC Questionnaires, and upload final 
version of study docs to notes and attachments. 
Updated By 
ashlmeye 
Update Time 
2020-12-10T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
December 8, 2020 
Action Date 
December 8, 2020 
Comments 
Amendment-005: Submitted to IRB 
Updated By 
stasulli 
Update Time 

2020-12-08T12:00:00.000Z 
Description 
Returned To PI 
Date 
December 5, 2020 
Action Date 
December 5, 2020 
Comments 
Amendment-005: Sending pre-review to study team. 
Updated By 
ashlmeye 
Update Time 
2020-12-05T12:00:00.000Z 
Description 
Annual Reminder Generated - Expedited or Full Board 
Date 
December 5, 2020 
Action Date 
December 5, 2020 
Comments 
Annual Reminder 
Updated By 
kc 
Update Time 
2020-12-05T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
November 24, 2020 
Action Date 
November 24, 2020 
Comments 
Amendment-005: Submitted to IRB 
Updated By 
stasulli 
Update Time 
2020-11-24T12:00:00.000Z 

Description 
Amendment Created 
Date 
September 8, 2020 
Action Date 
September 8, 2020 
Comments 
Amendment-005: Created 
Updated By 
stasulli 
Update Time 
2020-09-08T12:00:00.000Z 
Description 
Expedited Approval 
Date 
July 29, 2020 
Action Date 
July 29, 2020 
Comments 
Amendment-004: Approved 
Updated By 
khersber 
Update Time 
2020-07-29T12:00:00.000Z 
Description 
Assigned to Agenda 
Date 
July 29, 2020 
Action Date 
July 29, 2020 
Comments 
Amendment-004:  
Updated By 
khersber 
Update Time 
2020-07-29T12:00:00.000Z 
Description 

Submitted to IRB 
Date 
July 29, 2020 
Action Date 
July 29, 2020 
Comments 
Amendment-004: Submitted to IRB 
Updated By 
khersber 
Update Time 
2020-07-29T12:00:00.000Z 
Description 
Returned To PI 
Date 
July 29, 2020 
Action Date 
July 29, 2020 
Comments 
Amendment-004: open to prepare for approval 
Updated By 
khersber 
Update Time 
2020-07-29T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
July 29, 2020 
Action Date 
July 29, 2020 
Comments 
Amendment-004: Submitted to IRB 
Updated By 
stasulli 
Update Time 
2020-07-29T12:00:00.000Z 
Description 
Amendment Created 

Date 
July 26, 2020 
Action Date 
July 26, 2020 
Comments 
Amendment-004: Created 
Updated By 
stasulli 
Update Time 
2020-07-26T12:00:00.000Z 
Description 
Expedited Approval 
Date 
April 21, 2020 
Action Date 
April 21, 2020 
Comments 
Amendment-003: Approved 
Updated By 
khersber 
Update Time 
2020-04-21T12:00:00.000Z 
Description 
Assigned to Agenda 
Date 
April 21, 2020 
Action Date 
April 21, 2020 
Comments 
Amendment-003:  
Updated By 
khersber 
Update Time 
2020-04-21T12:00:00.000Z 
Description 
Submitted to IRB 
Date 

April 21, 2020 
Action Date 
April 21, 2020 
Comments 
Amendment-003: Submitted to IRB 
Updated By 
khersber 
Update Time 
2020-04-21T12:00:00.000Z 
Description 
Returned To PI 
Date 
April 21, 2020 
Action Date 
April 21, 2020 
Comments 
Amendment-003: open to prepare for approval 
Updated By 
khersber 
Update Time 
2020-04-21T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
April 17, 2020 
Action Date 
April 17, 2020 
Comments 
Amendment-003: Submitted to IRB 
Updated By 
stasulli 
Update Time 
2020-04-17T12:00:00.000Z 
Description 
Amendment Created 
Date 
April 3, 2020 

Action Date 
April 3, 2020 
Comments 
Amendment-003: Created 
Updated By 
stasulli 
Update Time 
2020-04-03T12:00:00.000Z 
Description 
Expedited Approval 
Date 
January 30, 2020 
Action Date 
January 30, 2020 
Comments 
Amendment-002: Approved 
Updated By 
khersber 
Update Time 
2020-01-30T12:00:00.000Z 
Description 
Assigned to Agenda 
Date 
January 30, 2020 
Action Date 
January 30, 2020 
Comments 
Amendment-002:  
Updated By 
khersber 
Update Time 
2020-01-30T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
January 30, 2020 
Action Date 

January 30, 2020 
Comments 
Amendment-002: Submitted to IRB 
Updated By 
khersber 
Update Time 
2020-01-30T12:00:00.000Z 
Description 
Returned To PI 
Date 
January 30, 2020 
Action Date 
January 30, 2020 
Comments 
Amendment-002: open to ensure study is on most current version of questionnaires 
Updated By 
khersber 
Update Time 
2020-01-30T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
January 27, 2020 
Action Date 
January 27, 2020 
Comments 
Amendment-002: Submitted to IRB 
Updated By 
stasulli 
Update Time 
2020-01-27T12:00:00.000Z 
Description 
Amendment Created 
Date 
December 18, 2019 
Action Date 
December 18, 2019 

Comments 
Amendment-002: Created 
Updated By 
stasulli 
Update Time 
2019-12-18T12:00:00.000Z 
Description 
Annual Reminder Generated - Expedited or Full Board 
Date 
December 5, 2019 
Action Date 
December 5, 2019 
Comments 
Annual Reminder 
Updated By 
kc 
Update Time 
2019-12-05T12:00:00.000Z 
Description 
Expedited Approval 
Date 
May 29, 2019 
Action Date 
May 29, 2019 
Comments 
Amendment-001: Approved 
Updated By 
slbenken 
Update Time 
2019-05-29T12:00:00.000Z 
Description 
Assigned to Agenda 
Date 
May 29, 2019 
Action Date 
May 29, 2019 
Comments 

Amendment-001:  
Updated By 
slbenken 
Update Time 
2019-05-29T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
May 29, 2019 
Action Date 
May 29, 2019 
Comments 
Amendment-001: Submitted to IRB 
Updated By 
williaud 
Update Time 
2019-05-29T12:00:00.000Z 
Description 
Returned To PI 
Date 
May 29, 2019 
Action Date 
May 29, 2019 
Comments 
Amendment-001: Comments from reviewer 
Updated By 
williaud 
Update Time 
2019-05-29T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
May 28, 2019 
Action Date 
May 28, 2019 
Comments 
Amendment-001: Submitted to IRB 

Updated By 
williaud 
Update Time 
2019-05-28T12:00:00.000Z 
Description 
Returned To PI 
Date 
May 28, 2019 
Action Date 
May 28, 2019 
Comments 
Amendment-001: Pre-Review 
Updated By 
williaud 
Update Time 
2019-05-28T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
May 24, 2019 
Action Date 
May 24, 2019 
Comments 
Amendment-001: Submitted to IRB 
Updated By 
elinder 
Update Time 
2019-05-24T12:00:00.000Z 
Description 
Returned To PI 
Date 
May 23, 2019 
Action Date 
May 23, 2019 
Comments 
Amendment-001: Pre-Review 
Updated By 

williaud 
Update Time 
2019-05-23T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
May 22, 2019 
Action Date 
May 22, 2019 
Comments 
Amendment-001: Submitted to IRB 
Updated By 
elinder 
Update Time 
2019-05-22T12:00:00.000Z 
Description 
Amendment Created 
Date 
May 17, 2019 
Action Date 
May 17, 2019 
Comments 
Amendment-001: Created 
Updated By 
elinder 
Update Time 
2019-05-17T12:00:00.000Z 
Description 
Expedited Approval 
Date 
December 5, 2018 
Action Date 
December 5, 2018 
Comments 
A Certificate of Confidentiality has been issued for this study. Subjects' identifiable 
sensitive research information must be protected in accordance with the terms of 
the certificate.; Research complies with and is subject to 45 CFR 46 effective January 

21, 2019 (i.e. Revised Common Rule or 2018 Requirements).; Waiver of informed 
consent per IU HRPP Policies; Waiver of documentation of informed consent per IU 
HRPP Policies; Waiver of authorization under 45 CFR 164.512(i); The PHI to be used 
or disclosed is determined to be necessary; The explanation of how this research 
involves no more than minimal risk of loss of privacy to the subject is sufficient; 
There exists an adequate plan to protect the identifiers from improper use and 
disclosure; There exists an adequate plan to destroy the identifiers at the earliest 
opportunity consistent with conduct of the research; There exist adequate written 
assurances 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 
research study, or for other research for which the use or disclosure of the requested 
information would be permitted by the Privacy Rule; The explanation of how this 
research could not be practicably conducted without waiver of authorization is 
adequate; The explanation of how this research could not be practicably conducted 
without access to and use of the individually identifiable health information is 
appropriate; Plan for soliciting the assent of the children and/or the parent/guardian 
permission is appropriate.; Child Category 404: not greater than minimal risk to the 
children; Waiver of assent for children per IU HRPP Policies; Waiver of 
parental/guardian permission approved per IU HRPP Policies; Waiver of 
documentation of parental/guardian permission per IU HRPP Policies 
Updated By 
droessin 
Update Time 
2018-12-05T12:00:00.000Z 
Description 
Assigned to Agenda 
Date 
December 5, 2018 
Action Date 
December 5, 2018 
Comments 
A Certificate of Confidentiality has been issued for this study. Subjects' identifiable 
sensitive research information must be protected in accordance with the terms of 
the certificate.; Research complies with and is subject to 45 CFR 46 effective January 
21, 2019 (i.e. Revised Common Rule or 2018 Requirements).; Waiver of informed 
consent per IU HRPP Policies; Waiver of documentation of informed consent per IU 
HRPP Policies; Waiver of authorization under 45 CFR 164.512(i); The PHI to be used 
or disclosed is determined to be necessary; The explanation of how this research 

involves no more than minimal risk of loss of privacy to the subject is sufficient; 
There exists an adequate plan to protect the identifiers from improper use and 
disclosure; There exists an adequate plan to destroy the identifiers at the earliest 
opportunity consistent with conduct of the research; There exist adequate written 
assurances 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 
research study, or for other research for which the use or disclosure of the requested 
information would be permitted by the Privacy Rule; The explanation of how this 
research could not be practicably conducted without waiver of authorization is 
adequate; The explanation of how this research could not be practicably conducted 
without access to and use of the individually identifiable health information is 
appropriate; Plan for soliciting the assent of the children and/or the parent/guardian 
permission is appropriate.; Child Category 404: not greater than minimal risk to the 
children; Waiver of assent for children per IU HRPP Policies; Waiver of 
parental/guardian permission approved per IU HRPP Policies; Waiver of 
documentation of parental/guardian permission per IU HRPP Policies 
Updated By 
droessin 
Update Time 
2018-12-05T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
December 5, 2018 
Action Date 
December 5, 2018 
Comments 
Submitted to IRB 
Updated By 
pattonle 
Update Time 
2018-12-05T12:00:00.000Z 
Description 
Returned To PI 
Date 
December 5, 2018 
Action Date 
December 5, 2018 

Comments 
Updated By 
pattonle 
Update Time 
2018-12-05T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
December 5, 2018 
Action Date 
December 5, 2018 
Comments 
Submitted to IRB 
Updated By 
elinder 
Update Time 
2018-12-05T12:00:00.000Z 
Description 
Returned To PI 
Date 
December 4, 2018 
Action Date 
December 4, 2018 
Comments 
Updated By 
pattonle 
Update Time 
2018-12-04T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
December 3, 2018 
Action Date 
December 3, 2018 
Comments 
Submitted to IRB 
Updated By 

elinder 
Update Time 
2018-12-03T12:00:00.000Z 
Description 
Returned To PI 
Date 
November 26, 2018 
Action Date 
November 26, 2018 
Comments 
Updated By 
pattonle 
Update Time 
2018-11-26T12:00:00.000Z 
Description 
Submitted to IRB 
Date 
November 21, 2018 
Action Date 
November 21, 2018 
Comments 
Submitted to IRB 
Updated By 
elinder 
Update Time 
2018-11-21T12:00:00.000Z 
Description 
Protocol Created 
Date 
November 13, 2018 
Action Date 
November 13, 2018 
Comments 
Protocol created 
Updated By 
elinder 
Update Time 

2018-11-13T12:00:00.000Z 
Administrative Details Form 
Protocol Details 
9031 
Protocol Type 
Expedited 
Billing Account # 
Study Status 
Submission Details 
9000 
Submission Review Level 
Expedited 
9030 
Expedited Category. 
Category 5: Data or specimens that have been or will be collected for nonresearch 
purposes 
Category 7: Survey, interview, focus groups, human factor, group behavior or 
characteristics 
9002 
Criteria for Approval. Select to confirm. 
Approved: The criteria for approval of the research are satisfied in accordance with 
IU HRPP Policies, and applicable federal regulations. 
Protocol Determinations 
9003 
Protocol Level of Risk. 
Minimal risk 
9020 
Is renewal required for this research? 
No 
9004 
Check all determinations that need to be made. 
Informed Consent Waiver 
HIPAA Waiver 
Vulnerable Population 
Certificate of Confidentiality 
9005 
Informed Consent Waivers 

Waiver of informed consent granted in accordance with IU HRPP Policies 
Waiver of documentation of informed consent granted in accordance with IU HRPP 
Policies. 
9006 
HIPAA Waivers 
Participation 
9010 
Brief description of PHI - Participation 
FGID Module: Data points collected for participation in the retrospective review of 
FGID module data include date(s) of visit, physician name, patient vitals and 
demographics, contact information, patient/parent answers to GI questions, who is 
answering the questions (parent or patient or both), and physician notes about GI 
diagnoses, treatments, and recommendations. Survey (online and phone): In 
addition to the FGID data points above, we will use parent and patient answers to 
the phone survey along with parent-reported demographics. Baseline retrospective 
review: DOB, date/diagnosis (ICD codes), Eskenazi clinic(s) of care Health care 
utilization retrospective review: The presence of outpatient sick visits within the 
CHICA system clinic for any complaint; The presence of outpatient sick visits within 
the CHICA system clinic with an associated GI billing code; The presence of visits to 
statewide providers, including inpatient hospital stays, outpatient clinic visits, and 
emergency room visits.; The occurrence of any GI-related testing and procedures – 
specifically radiologic, laboratory testing, endoscopy, and surgical procedures related 
to GI diagnoses; The use of any medications prescribed to treat Rome IV diagnoses – 
specifically acid-suppressants, antispasmodics, antidepressants, stool softeners and 
laxatives, and pro-motility agents. 
9009 
Participation HIPAA Waiver 
Alteration of authorization criteria satisfied in accordance with 45 CFR 
164.512(i)(2)(ii). Alteration of authorization approved in accordance with 45 CFR 
164.512(i). 
Waiver of authorization criteria satisfied in accordance with 45 CFR 164.512(i)(2)(ii). 
Waiver of authorization approved in accordance with 45 CFR 164.512(i). 
9011 
Identify population(s) involved in this research. 
Children 
9012 
Involvement of Children: Select to confirm. 
The involvement of children in the research is appropriate in accordance with IU 
HRPP Policies. 

9013 
Children Category. 
The involvement of children in the research satisfies the conditions of Category 404 
in accordance with IU HRPP Policies. 
9014 
Parental Consent/Waivers. Choose all that apply. 
The plan for soliciting parental/guardian permission is appropriate in accordance 
with IU HRPP Policies. 
Waiver of parental/guardian permission granted in accordance with IU HRPP Policies. 
Waiver of documentation of parental/guardian permission granted in accordance 
with IU HRPP Policies. 
9015 
Child Assent. Choose all that apply. 
The plan for soliciting and documenting assent from children is appropriate in 
accordance with IU HRPP Policies. 
Waiver of assent from children who are otherwise capable of providing assent 
granted in accordance with IU HRPP Policies. 
9025 
Certificate of Confidentiality. 
The research is subject to the NIH Policy for Issuing Certificates of Confidentiality and 
therefore has been issued a Certificate. 
9028 
Other Determinations.