Targeted Fortification of Human Breast Milk and Adjustment of TPN for Very Low Birth Weight Infants to Optimize Growth and Nutrition Using the Miris Mid-infrared Human Milk Analyzer
Phase: NA
Conditions: Human Milk, Neonate, Breast Milk
Sponsor: MetroHealth Medical Center

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Date: Wednesday, June 19, 2019 9:27:54 AM
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View: 01-00 Study Information
 
1.0 Study Information:
 
1.1 
* Short Title: Targeted Breast Milk Fortification
The Short Title Should be the sponsor protocol number. If there is no sponsor protocol, then enter 3-
5 words or numbers that capture the important study characteristics and help identify the study. 
 
 
1.2
* Full Title of Research Project: 
Targeted fortification of human breast milk and adjustment of TPN for Very Low Birth Weight infants
to optimize growth and nutrition using Miris mid infrared human milk analyzer
 
Enter the Full
Title of the
study. 
 
1.3 
Principal Investigator: Sharon Groh-Wargo
 
HSR Certification Status:   Certified   HSR Certification Expiration Date:   9/1/2019 ;
COI Expire Date: 10/27/2019 ; COI Yes or No: Yes ; COI Management Plan: Yes ; PI Non-
Compliance:   
 
 
The PI must
be a
MetroHealth
Staff person or
have privileges
to practice at
MHS. The PI 
must assume
full
responsibility
for the conduct
of the study.  
 
 
  
 
 
1.4
Key Personnel: 
 
Name
CREC
Status
CREC
Expiration
COI COI Expire Management
Plan?
Study Roles Employer
Name
Non-
Compliance
View Stacey
Ramey
Certified 6/26/2021
no
9/14/2019  
eIRB
Notification
Recipient 
Responsible
Investigator
(Resident
PI one RI
required) 
Obtaining
Informed
Consent 
DRA (only
one) 
The
MetroHealth
System
 
View Stephanie
Merlino
Certified 6/1/2022
no
5/13/2020  
Obtaining
Informed
Consent 
Co-
investigator 
The
MetroHealth
System
 
View Mathavan
Sivarajah Certified 12/17/2021 no
5/6/2020
 
Obtaining
Informed
Consent 
The
MetroHealth
System
 
 
 
 
 
 
Add
additional Staff
as needed.
Update to add
Study Roles
If using Epic,
add role of
DRA to one
person
 
 
 
1.5
Type of Research: 
Other
 

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1.6
If "Other" Type of Research Please Explain: 
Randomized clinical research study
 
View: 01-01 Study Information
 
 
1.1    Study Information:
 
1.7
* Department-What Department approvals are required? 
Name
Pediatrics
 
 
 
 
 
 
 
 
1.9 
Definitions to keep in mind when selecting the degree of risk:
Minimal Risk is defined in 45CFR46 and in FDA regulations 21CFR50.3 as:  
Minimal risk means that the probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those
ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests.
 
 
 
 
* Degree of Risk: (This is the investigator's assessment of the risks
involved in the research which will informed the IRB Decision but which
will not automatically be accepted. The Board is the final arbiter of risk.
The risk level will be set by the IRB staff at the time of approval.) 
 
Name
Risk
Not Greater Than Minimal Risk
 
 
 
 
 
 
Select most appropriate one.
 
1.10
 
 
 
 
 
* Type of IRB Review Requested: 
Full Board 
 
 
 
Select one. If you select
Exempt or Expedited you will
be taken to that section when
you hit continue.
View: 01-02 Study Information
 
1.2 Study Information:
 
1.11 
Will you require access to Epic to conduct this study?   
Yes 
No 
  
***The DRA's employee number must be listed on their registration
form.***  
 
If you answer this question yes
you will need to identify a
Designated Records
Administrator one person only.
 
 Please add the role of "DRA" to one study staff member on page 1 of the
application.
 
 
1.12 
Is the Principal Investigator a resident or trainee? 
  
Yes 
No 
 
 
Please check yes or no. 
 
 
NOTE: Residents, Fellows, and non-MHS Personnel cannot be listed as the Principal
Investigator
 

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View: 01-03 Study Information
 
 
1.3    Study Information:
 
 
 
1.13  
* Will CRU Be Used: 
Yes  If you answer yes to this question this application will be sent to the CRU for
review after departmental review and before it is submitted to the IRB.
 
Will the CRU be used?  
 
1.14
* Has this research protocol ever been submitted to another CASE
affiliated IRB (i.e. UH, CCF, VA or CASE)? 
No
 
 
If this study has been reviewed
at another CASE affiliated IRB
you should answer yes.
 
1.15  
 
If yes, was it: 
 
 
Select one from drop down
menu.
 
1.16 
 
 
 
 
 1.17
Please supply the following information: At which institution was it
approved? If it was disapproved, why was it disapproved? 
Please attach the Approval letter/letters from other IRBs (i.e. UH,
CCF, VA or CASE):  
Name
Description
There are no items to display
 
 
What institutions have
approved this study. If it has
been disapproved, please give
a brief explanation of why
study was disapproved.
 
Please attach approval
letter/letters.
View: CRU 01-01 Application
 
Please Note: If you are using the CRU you must adhere to the following New NIH Public Access Policy: 
Please review the information provied by theis link regarding enforcement of the NIH Public Access Policy  that will begin on
April 1, 2013.  The most recent changes to the NIH Public Policy are explained in the attached Power point presentation from
the NIH (January 15, 2013) and the attached MS-Word document, "Manuscript Submission to PubMed Central for a PMCID".
 
All studies that utilize the MetroHealth CRU resources (space, nursing, lab, bionutrition) that are non-industry funded, are
required be NIH Public Access Policy compliant by obtaining a PMCID number.  The PMCID number is an separate index from
the PMID - the PMCID number indexes the entire publication while the PMID indexes the abstract, only.  In addition to the
PMCID number, investigators are required to post their publications on 'My Bibliography' and link their publications to grant
numbers.
 
Attention to this policy is important because the NIH will halt the process of renewals, re-submissions and certain progress
reports if relevant publications are non-compliant with the PMCID number and My Bibliography.  Continued use and funding of
the CRU may be jeopardized if appropriate publications are not fully compliant. 
 
In addition, please ensure that studies utilizing the CRU also acknowledge the CTSC grant in their publications and cite the
CTSC grant number, UL1TR000439.  This is a NEW NIH CTSC grant number that went into effect on June 1, 2012. The
acknowledgment and grant number can also be found by going to the Cleveland CTSC website acknowledgments page. (This
page also has information about the NIH Public Access Policy.)
 
Thank you in advance for ensuring that all publications from studies utilizing CRU resources (that are not-industry
supported) are compliant with these requirements as soon as possible.
 

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1.00 CRU Application [Since you have indicated in your application that you want to utilize the resources of
the CRU Please complete the following pages of the IRB Application. Hit the continue button to move from page to
page  in that way you will be able to take advantage of the built in branching logic to complete your CRU
application.]
 
1.01
Is this an HIV/AIDS Project:   
Yes 
No
 
HIV/AIDS?
 
1.02
Are you currently Funded by NIH?    
Yes 
No
 
 
If yes please add grant or
contract number.
 
1.03
Would you like to conduct your study on the CRU?   
  
Yes 
No
 
Yes or No
 
1.04
What is your eRA Commons Name? 
 
eRA Commons Name required
for all non- industry studies
 
1.05
Anticipated Start Date: 
5/20/2019
Anticipated End Date: 
3/31/2021
 
Anticipated Date Study to
Begin (1st Patient)
Anticipated End Date
 
1.06
 
Approximate Inpatient Days Per Subject: 
90
Approximate Outpatient Visits Per Subject: 
0
 
Enter approximate numbers
 
1.07
 
After August 2010 this is a read only copy of the paper CRU Resource Application:  
Name
Version
There are no items to display
 
Old CRU Application forms
 
1.08
These are your target enrollment numbers for the ethic and racial
categories below:
 
Ethnic Category
 
 
 
 
 
  Sex/Gender
 
 
 
 
 
Ethnic Category
Females 
Males
  Total
 
 
Hispanic or Latino
  5
5
  10
 
 
Not Hispanic or Latino
  25
25
  50
 
 
Ethnic Category Total of All Subjects
  30
30
  60
 
 
 
 
 
 
 
 
Racial Category
 
 
 
 
 
Females
Males
  Total
 
 
American Indian/Alaska Native
0
0
  0
 
 
Asian
1
1
  2
 
 
 
Native Hawaiian or Other Pacific
Islander
0
0
  0
 
 
Black or African American
17
17
  34
 
 
 
White
12
12
  24
 
 
Enter anticipated numbers for
this protocol

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Racial Categories Total of all Subjects
30
30
  60 
 
 
View: CRU 01-02 CRU Resource Needs
 
 
 
2.00 CRU: Resource Needs
 
Hospital Lab Tests:   
Yes 
No
 
 
Hospital Lab Tests = CRU draws
blood and send it to Hospital Lab
or forwards blood already drawn
to Hospital Lab
 
Human Performance Lab Tests and Measurements: 
  
Yes 
No
 
 
Human Performance Lab Tests
and Measurements
 
Research Nutrition Services:   
Yes 
No
 
 
Research Nutrition Services
 
CRU Laboratory Services:   
Yes 
No
 
 
Core Laboratory Services (7:00
am to 5:30 pm, weekdays)
 
Use of CRU Facilities or Equipment Only:   
Yes 
No
 
 
Use of CRU Faciities or
Equipment Only
 
 
 
 
 
 
 
 
 
Nursing Resources:   
Yes 
No  
 
Spanish Translation Services:   
Yes 
No  
 
Spanish Interpertation Services:   
Yes 
No
 
Use CRU Nurses
 
Translation is the rendering of a
written text in one language in a
comparable written text in
another language
Interpreting is the oral rendering
of spoken or signed
communication from one
language into another.
 
 
 
 
View: CRU 01-03 CRU Nursing Resources
 
1.03 CRU: Nursing Resources
 
 3.01
CRU Nursing Visits: 
 
Please Add Each Visit  
 

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Title
Visit
#
Visit
Length
Admissions Comments
 
Title
Visit
#
Visit
Length
Admissions Comments
View Targeted breast milk
fortification
1
60
Minutes
no
CRU will obtain PEAPOD prior to
discharge
 
 
View: CRU 01-06 Human Performance Lab Tests and Measurements
 
1.06 CRU: Human Performance Lab Tests and Measurementes
 
6.01 
Exercise Training:   
Yes 
No
 
Answer Yes or No
 
6.02
Exercise Training Description: 
 
Describe the exercise training
 
How many times per week
 
6.03
Exercise Training # Times/Week: 
 
 
Answer Yes or No
 
6.04
Treadmill:   
Yes 
No
 
 
6.05
Treadmill Description: 
 
Description of treadmill
exercises
 
6.06
Ergocycle:   
Yes 
No
 
Answer Yes or No
 
6.07
Ergocycle Description: 
 
Describe the use of the
ergocycle
 
6.08
Other Activities:   
Yes 
No
 
Answer Yes or No
 
6.09
Description of Other Activities: 
 
Describe "Other" activities
View: CRU 01-07 Research Nutrition Services
 
7.00 CRU: Research Nutrition Services
 
7.01
Research Measurements:   
Yes 
No
 
Answer Yes or No
 
7.02 
BIA:   
Yes 
No
 
Answer Yes or No
 
7.03
BIA Measurements Per Subject: 
 
Enter # of measurements
 
7.04
Anthropometry:   
Yes 
No
 
Answer Yes or No
 
7.05
Anthropometry Measurements Per Subject: 
1
 
Enter # of measurements
 
7.06
Indirect Calorimetry:   
Yes 
No
 
Answer Yes or No
 
7.07
Indirect Calorimetry Number Per Subject: 
 
Enter # of measurements
 
7.08
Weigh Backs:   
Yes 
No
 
Answer Yes or No

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7.09
Weigh Backs Number: 
 
Enter #
 
7.10
Other Research Measurements: 
 
Describe other measurements
 
7.11
Bionutrition Services:   
Yes 
No
 
Answer Yes or No
 
7.12
Nutrition Assessment Or Counseling:   
Yes 
No
 
Answer Yes or No
 
7.13
Food Record Analysis:   
Yes 
No
 
Answer Yes or No
 
7.14
Food Frequency Questionnaire:   
Yes 
No
 
Answer Yes or No
 
7.15
Research Diet Or Menu Development:   
Yes 
No
 
Answer Yes or No
 
7.16
Research Diet Or Menu Development Description: 
 
Describe diet or menu
developement
 
7.17
Other Bionutrition Services: 
 
Describe other Bionutrition
services
 
7.18
Research Meal Services:   
Yes 
No
 
Answer Yes or No
 
7.19
Research Meal Service Type of Meal: 
 Type of Meal
Number Of Meals Per Subject
Other
There are no items to display
 
Click add and answer the
questions contained on the
form.
 
 
View: CRU 01-09 Additional Notes or Requests
 
1.09 CRU: Additional Notes or Requests
 
 9.01
If you have any additional notes or requests from the Clinical Research Unit that
have not been covered, please describe them here: 
 
 
 
 
View: 01-04 Study Information
 
1.4 Study Information
These Questions are specifically about the adequacy of resources, are there the necessary resources to
complete this study? There are two questions which focus on nursing resources. If this research will
require the use of nursing resources then the Nursing Resources Form found on the IRB Home Page
under forms and templates will need to be completed and attached to this research application.
     
 
1.18 
Can you assure the IRB that there are adequate numbers of qualified staff
to conduct this research? 
  
Yes 
No
 
Please answer yes or no. This is
an assurance to the IRB.
 
1.19
How will the investigator ensure that persons assisting with the research
were adequately informed about the protocol and their research-related
duties and functions and requirements for maintaining the confidentiality
of all data? 
Regular meetings will be held to update all co-investigators and study
staff about the interventions planned and outcomes measured. 
 
i.e. investigator meeting,
formal protocol review with PI,
monitor, sponsor. 
 
1.20 
Will the PI and study staff have sufficient time to conduct and complete
the research? 
  
Yes 
No
 
Please answer yes or no. This is
an assurance to the IRB.
 
1.21
What facilities are available to conduct the research? Are they adequate?
Please describe. 
Study personnel are health care professionals working in the Neonatal Intensive
Care Unit (NICU) at Metrohealth and have access to the study population. A space
has been designated in NICU which will function as the milk lab for mixing the
 
Please describe the facilities,
i.e. lab, procedure room,
chemo treatment room.

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milk. Analysis of the human milk will be done in the lab at Metrohealth using the
Miris human milk analyzer.
Nursing Resources:
 
1.22
Is this study using MetroHealth staff nurse time or labor ? (i.e. giving
medcations, teaching, or additional documentation)  
  
Yes 
No
 
This is in addition to the time of
the study/research nurse.  
 
1.23
Attach Nursing Resources Form here:
 
Click here for Nursing
Resources form 
Open the form, Complete the
form and save it to your files
then attach it to the study by
hitting the browse file and
selecting the file and hitting
OK.
Click here for the MHS Policy
 
 
 
 
 
 
 
 
 
View: 04-00 Scientific Review
 
4.0 Scientific Review:
All Studies need a Science Review. Has your study been reviewed by any of the
following?
 
4.1 
Please Check all that Appy to this study so that the IRB may make a
determination if there needs to be further scientific review:  
 
Review Type
Initiated and sponsored by industry under an IND, IDE, HDE, or 510K
exemption issued by the FDA for which no scientific integrity concerns were
identified during the FDA review process
Trial initiated and sponsored by industry that has undergone a scientific merit
review by the sponsoring agency, but is not being conducted under an IND,
IDE, HDE, or 510K exemption
Sponsored by a Cooperative Group
Proposed research has been awarded funding by a federal agency
Peer reviewed by a federal funding agency and received a favorable funding
score
Peer reviewed by a federal funding agency with the acknowledgment of
scientific merits, but not likely to be funded for reasons unrelated to scientific
merit
Sponsored by a foundation or a private agency that requires a separate
scientific merit review process at the sponsoring agency
No Science Review
 
Select all that apply. Note FDA
Approval does not equal science
review.
 
4.2
Do any of the following apply to your study? Please check all that apply: 
Additional Reasons Why Science Review May Be Required
Investigator-initiated study
 
Check all that apply your
answers will assist the IRB in
deciding if further science review
is necessary.
 
4.3 
Does this study require review by the Biosafety Committee? 
No
 
All studies involving
vaccines, potentially hazardous

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materials or genetic research
must go to the biosafety
committee at CASE.
 
4.4
Does this study require review by the Radiation safety committee?  No
 
If a study involves more than
routine exposure to radiation on
the part of subjects the study
must go to the radiation safety
committee.
 
4.5
Does this study require Review by the Nursing Committee? 
No
 
The nursing committee must
review all studies where the PI is
a nurse, and all studies which
have as the primary objective to
contribute to nursing
knowledgebase, and/or have
implications for nursing practice.
View: 05-00 Funding Information I
 
5.0   Funding Information I:
All Research Projects must have an identified funding source! 
 
5.1 
Is this research externally funded? No  
Research can be both externally and internally funded so you can answer yes to both
5.1 and 5.6. 
 
Check one
 
5.2
Types Of External Funding: 
Name
There are no items to display
 
Check all that apply.
 
5.3 
If other, external funding please explain: 
 
If other please describe.
 
5.4
Sponsor Information: 
Name Sponsor/Agency
Address
Telephone
FAX
Contact Person
There are no items to display
 
Please supply this information
as your application can not be
processed without it.
 
5.5
Have you received and/or submitted a Notice of Award or Contract? 
No
 
If yes, attach your Notice of Award letter here (not your grant):  
Name
Version
There are no items to display
 
Select one from drop down
menu.
Attach notice of award.
View: 05-01 Funding Information II
 
5.1  Funding Information II
 
5.6 
Is Research Internally Funded (internal funding is any
MetroHealth System or MetroHealth Foundation funds):
 
  
Yes 
No
 
 
Check one, research can be both externally and internally
funded so you can answer yes to both 5.1 and 5.6.
 
5.7
Internal Funding Sources List: 
Internal Funding Source
Department Operating Budget
 
Check all the apply.
 
5.8 
If a MetroHealth Foundation funds or any MetroHealth
 
Check yes or no.

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System funds are being used, has department approval
been received? 
  
Yes 
No  
 
5.9
If a MetroHealth Foundation funds or any MetroHealth
System funds are being used indicate the Account
Number: 
 
Please enter the account number if this applies.
 
5.10
* Are there current Conflict of Interest Forms for all
Key Personnel? [It is the responsibility of the Principal
Investigator to ascertain this information and check
this box.]  
  
Yes 
No
This quesƟon is not asking if there are COI forms for all Key Personnel
it is asking if all Key Personnel have current COI forms so that any SFI
is reported and can be dealt with if a management plan is need or
reporƟng to NIH is required.
 
In order to submit a new protocol all COI Forms for key
personnel and invesƟgators must be current = provide up to
date informaƟon.
 
5.11 
Please check below any Conflicts of Interest
(Financial) you as Principal Investigator or your study
staff [Co-Investigator, Coordinators, Other Study Staff]
may have on this Study: 
Potential Conflict of Interest
None of the above options apply and there are no other
financial conflicts of interest in the conduct of this research.
 
This quesƟon pertains to this study and is not a general
quesƟon. Check all that apply.
You and/or your study staﬀ will need to ﬁle a Conﬂict of
Interest Disclosure Form annually.
If anyone working on this study has a Conﬂict of Interest or
a perceived conﬂict. This informaƟon will need to be
included in the consent form i.e. company is paying MHS to
do this study. 
 
5.12 
Please attach a copy of your grant application here: 
Name
Description
There are no items to display
 
You must aƩach a copy of your grant applicaƟon here (i.e.
NIH Grant ApplicaƟon).
You have the opƟon to aƩach a copy of the budget, clinical
trial account authorizaƟon form, contract and Approval
leƩer(s) now or you can email them to your grants
management specialist in the RABO oﬃce.
Copies of all RABO forms are available at:
http://www.metrohealthresearch.org/raboforms.html
 
 
View: 06-00 Performance Site Information
 
6.0 Performance Site Information:
 
6.1 
At what sites will the study team be performing this research,
(please enter  information about all non-MHS sites in 5.2): 
Name
The MetroHealth System
 
If this study is being done at MetroHealth where is it being done give the
physical location (i.e. 8B, ED, Broadway, Old Brooklyn, PICU, Cath Lab): 
MetroHealth Main Campus- NICU and CRU  
 
Select all that apply. If  you
select other please enter
information about that site in
question 6.2.
 
 
 
 
 
 
Where is the research going to be
done? What physical location on

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the Main campus or the
community health centers?
 
6.2
Please provide information about other external sites here: 
Name of Site
Address
Telephone Number
There are no items to display
 
  
 
Please enter contact
information. Please include name
of facility, address and
department.
 
6.3 
If you are doing this research at an external site does this site have an
IRB? 
  
Yes 
No 
 
Select yes or no. 
 
6.4
If the External Site has an IRB will that IRB defer review to the MHS IRB? 
  
Yes 
No 
 
 
This  only applies if there is no
IRB or if there  is  a legal 
agreement between
institutions permitting a
reciprocal review, i.e. CASE.
 
6.5
Attach letter from external site agreeing to permit the MHS to review this
protocol: 
Name
Description
There are no items to display
 
  
 
Attach letter.
 
6.6
Has the external site granted permission for the research to be
conducted? 
  
Yes 
No 
 
 
This applies to sites where there 
is no IRB and
the investigator must get  a 
letter  from the site that gives
permission to conduct the
research  at the site.
 
6.7
Attach letter from external site granting permission for the research to be
conducted: 
Name
Description
There are no items to display
 
 
 
Attach letter of support. 
 
View: 06-01 Performance Site Information
 
6.1 Performance Site Information
 
6.8 
 Is MHS the lead institution of a multi-site study?   
Yes 
No 
 
 
Please answer yes or no. 
 
6.9
If yes, is there a plan to communicate information obtained through
research that might be relevant to the protection of human subjects,
including a plan to provide the IRB with information on unanticipated
events, interim results, and protocol modifications. 
  
Yes 
No 
  
 
Please answer yes or no.
 
6.10 
Please give a detailed explanation of the above plan: 
 
 
 
This plan must give the IRB
enough information to decide if
the plan is appropriate and
adequate. 
 
6.11
Will the Principal Investigator conduct this study at any location outside
the United States of America? 
  
Yes 
No 
 
 
Answer these questions only if
there are research sites outside
the USA.
 
6.12
Country, City, and address: 
Country
Address of Research Facility
There are no items to display
 
Give country and location.

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View: 07-00 Research Objectives and Background
 
7.0 Research Objectives and Background:
 
7.1 
* ABSTRACT: Please give the IRB a 500 word Abstract that contains
the specific objectives of the study. 
Breast feeding is the preferred method of feeding in newborns and breast milk is
the safest form of enteral nutrition for premature infants. The American Academy
of Pediatrics’ policy statement recommends exclusive breast feeding for 6
months, and until 12 months as complimentary foods are introduced. Premature
infants have difficulty achieving this recommendation due to multiple barriers
created by the neonatal intensive care unit (NICU). One of these barriers is the
increased caloric and nutrient requirements, compared to term infants, making it
necessary to add fortification to maternal breast milk. Despite these barriers,
breast milk has the potential to be the most beneficial for premature, critically ill
infants. Preterm infants fed human milk, compared to those fed formula, have a
decreased risk for necrotizing enterocolitis, sudden infant death syndrome
(SIDS), respiratory syncytial virus (RSV) bronchiolitis, respiratory infections, and
many other childhood conditions. There is variability in macronutrient and caloric
content of breast milk between mothers, making it difficult to accurately quantify
the nutritional content the breast milk is providing. The protein content varies by
postnatal age, and the fat content varies temporally during a feed. Currently
calculations use a standard value for caloric density and macronutrient content of
breast milk, which is a reported average, but not necessarily specific to each
individual mother.  
Human milk analysis has been used to address this variability. The Miris Human
Milk Analyzer (HMA) is a mid-infrared analyzer and has been evaluated in many
studies. It measures the macronutrient content of breast milk, providing values
for protein, fat, carbohydrates, and calculated calories. By having this
information available, the fortification added to breast milk can be tailored
specifically to each mother’s breast milk composition to meet each neonate’s
nutritional needs, and optimize growth. As of December 2018, the Miris HMA has
obtained FDA approval in the United States. 
This will be a prospective randomized control study of preterm infants less than
1500 grams [very low birth weight (VLBW)] receiving human milk (maternal or
donor) will be included. The control group will receive adjustment of total
parenteral nutrition (TPN) per NICU guidelines as enteral feedings are advanced
followed by standard fortification of human milk. The intervention group will have
TPN (protein and lipids) adjusted based on analysis of human milk as feedings
are advanced to provide goal 4g/kg/day of protein and 100-130 kcal/kg/day
followed by targeted fortification of breast milk based on human milk analysis to
continue to provide 4 g/kg/day of protein and 100-130 kcal/kg/day for once full
feeds are achieved. The primary aim of this study is to evaluate the growth,
anthropometric measurements, and body composition, to see if targeted
fortification improves neonatal growth. By optimizing neonatal growth and
nutrition there is potential to also have an impact on other morbidities and long
term neurodevelopmental outcomes.  
 
This is your abstract also known as
a synopsis from an industry
sponsored study.  Please
limit to 500 words.
 
7.2
* What are the specific aims of this study i.e. what are the
question(s) this research intends to answer? Provide at a maximum 3
primary and 3 secondary aims.  
The aim of this study is to demonstrate improved growth and body
composition in VLBW infants by using human milk analysis as a tool to
guide when adjusting TPN and lipids followed by targeted fortification of
breast milk at full feeds to provide 4g/kg/day of protein 100-130
kcal/kg/day, compared to those who receive standard management of
TPN per guidelines and standard fortification.  
The primary outcome measured will be body composition measurement
4 weeks after achieving full feeds with targeted fortification, or at NICU
discharge, whichever comes first.  
Secondary outcome variables:  
1) Weight gain velocity 
2) Anthropometric measurements including weight, length, head
circumference, and mid upper arm circumference or skinfold thickness 
 
 This is your Hypothesis also know
as your aims (NIH) or safety and
efficacy aims (industry). Please list
no more than 3 primary and 3
secondary clearly label these aims
primary and secondary.
 
7.3
Please provide a summary of the present knowledge relevant to the
research and make citation to any applicable scientific literature: 
 
This is your literature search and
bibliography. Also known as

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Breast feeding is the preferred method of feeding in newborns and breast milk is
the safest form of enteral nutrition for premature infants. The American Academy
of Pediatrics’ policy statement recommends exclusive breast feeding for 6
months, and until 12 months as complimentary foods are introduced [1].
Premature infants have difficulty achieving this recommendation due to multiple
barriers created by the neonatal intensive care unit (NICU). One of these barriers
is the increased caloric and nutrient requirements, compared to term infants,
making it necessary to add fortification to maternal breast milk [5]. Despite
these barriers, breast milk has the potential to be the most beneficial for
premature, critically ill neonates. Preterm infants fed human milk, compared to
those fed formula, have a decreased risk for necrotizing enterocolitis, SIDS, RSV
bronchiolitis, respiratory infections, and many other childhood conditions [1]. The
variability in macronutrient and caloric content of breast milk makes it difficult to
accurately quantify the nutritional content the breast milk is providing. The
protein content varies by postnatal age, and the fat content varies temporally
during a feed[2]. Human milk analysis has been used to address this variability.
The Miris Human Milk Analyzer (HMA) is a mid-infrared analyzer and has been
evaluated in many studies[3]. It measures the macronutrient content of breast
milk, providing values for protein, fat, carbohydrates, and calculated calories. By
having this information available, the fortification added to breast milk can be
tailored specifically to each mother’s breast milk composition, and each neonate’s
nutritional needs [4]. As of December 2018, the Miris HMA has obtained FDA
approval in the United States. 
 
1. American Academy of Pediatrics Section on Breastfeeding: Breastfeeding and
the use of human milk. Pediatrics 2012, 129(3):e827-841. 
2. Martin, C., Ling, P., & Blackburn, G. (2016). Review of Infant Feeding: Key
Features of Breast Milk and Infant Formula. Nutrients, 8(5), 279.
doi:10.3390/nu8050279 
3. Fusch, G., Kwan, C., Kotrri, G., & Fusch, C. (2017). “Bed Side” Human Milk
Analysis in the Neonatal Intensive Care Unit. Clinics in Perinatology, 44(1), 209-
267. doi:10.1016/j.clp.2016.11.001 
4. Miris. Our Solution. 2019. Available at https://mirissolutions.com/solution.
Accessed March 8, 2019.  
5. Tudehope, D. I. (2013). Human Milk and the Nutritional Needs of Preterm
Infants. The Journal of Pediatrics, 162(3). doi:10.1016/j.jpeds.2012.11.049 
Background and significance (NIH)
or Introductory Section from
industry sponsored trial.  
 
7.4
Option to Upload Documents related to question 7.3: 
Name
Description
There are no items to display
 
If it is easier to attach your
response to question 7.3 please do
so here. Please limit to three
pages.
View: 08-00 Methods and Procedures I
 
8.0 Methods and Procedures I:
 
8.1 
Will this research involve the following Social-Behavioral Procedures: 
Name
None of the Above Social-Behavioral Procedures Apply to this Study
 
Check all that apply.
 
8.2
Will this research involved any of the following Medical
Procedures/Considerations: 
Name
Study of Human Biological Materials (i.e. Urine Collection)
Study of Existing Data
Medical Tests, Comparisons, Evaluations
Special/prescribed diets
Anthropomorphic Measurments
 
Check all that apply.
 
8.3 
Identify Data Collection types for this study: 
Name
Chart Review - Prospective
Anthropomorphic evaluations
 
Check all that apply.
Note if you are doing,
recordings, Video-
Recording/Photographs then
subjects will need to sign the
MetroHealth Audio-Video
Consent form. See the IRB
Forms and Templates.

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View: 08-01 Methods and Procedures II
 
8.1 Methods and Procedures II:
 
8.4 
* Please specify in detail the methods and procedures that are involved in
this research: 
In the NICU, there is a feeding protocol in place for all infants that is based on their
birth weight. All infants less than 1500 grams at birth are placed on starter total
parenteral nutrition, and delayed initiation of enteral feeds determined by birth
weight. The standard feeding protocol is as follows:  
 
Maternal breast milk (MBM) is preferentially used, or donor breast milk (DBM) if
maternal milk is unavailable and the mother has consented to the use of donor
breast milk. 
 
Infants <750 grams are nil per os (nothing by mouth, or NPO) for 10 days followed
by initiation of priming feed of 0.5 ml every 2 hours for 10 days, after which feeds
are increased by 0.5 ml/feed every other day until they reach 100 ml/kg/day. They
then increase by 10 ml/kg/day until they reach full feeds of 150 ml/kg/day.  
Infants with birth weight 750-1000 grams are NPO for 7 days followed by initiation
of priming feed of 1 ml every 2 hours for 7 days, after which feeds are increased by
0.5 ml/feed daily until they reach 100 ml/kg/day. They then increase by 10
ml/kg/day until they reach full feeds of 150 ml/kg/day. 
Infants with birth weight 1001-1250 grams are NPO for 4 days followed by
initiation of priming feeds of 1.5 ml every 2 hours for 4 days, after which feeds are
increased by 1 ml/feed every other day until 100 ml/kg/day. They then increase by
10 ml/kg/day until they reach full feeds of 150 ml/kg/day.  
Infants with birth weight 1251-1500 grams are NPO for 1 day followed by priming
feeds of 2 ml for 2 days, after which they increase by 20 ml/kg/day until they
reach full feeds of 150 ml/kg/day.  
Once enteral feeds reach 50 ml/kg/day MBM is fortified with 1 packet of human
milk fortifier for every 50 ml of breast milk. Then at 75 ml/kg/day MBM is fortified
with 1 packet of human milk fortifier for every 25 ml of breast milk. 
As enteral feedings are advance the total parenteral nutrition is gradually
decreased. The control group will have TPN and SMOF lipid adjusted per NICU
guidelines and standard practice until full enteral feeds are achieved. The protein
provided in TPN is adjusted based on volume being given and what will fit inside
the TPN due to concentration, and lipids are usually decreased by 50% when the
enteral nutrition is providing 75 ml/kg/day, and then discontinued with enteral
nutrition is providing 100 ml/kg/day. The intervention group will have protein
content of the TPN and SMOF lipid adjusted dependent on the breast milk
composition- goal 4g/kg/day protein, 100-130kcal/kg/day.  
This study will be a randomized control trial with 2 arms. Patients will be
randomized to either the control group (standard fortification) or intervention
group (targeted fortification) in a 1:1 allocation ratio. Twins will be considered as
one and allocated to the same group. Allocation group will be stratified to four
groups according to birth weight: <750g, 751-1000g, 1001-1250g, 1251-1500g.
This stratification is based upon our NICU feeding guideline, and will ensure that
enrolled infants will receive comparable nutrition progression (e.g. NPO days, days
of trophic feeds) throughout the study period. The allocation will be concealed in a
sequentially numbered, opaque, sealed envelope, that will be opened after consent
is obtained. After randomization, the groups will not be blinded to the investigators
or caregivers.  
 
All VLBW infants whose mothers consent to provide breast milk and participate in
the study will be included. In the control group, breast milk will be fortified per
protocol as listed above and TPN weaned per NICU guideline. The intervention
group will receive standard fortification with additional added liquid protein to
provide 4 g/kg/day and microlipid to provide 100-130 kcal/kg/day once 100
ml/kg/day of enteral feeds are achieved. Once the infants reach goal enteral feeds
of 150ml/kg/day they will continue on the standard or targeted fortification for 4
weeks.  
 
The mothers will provide breast milk when they come to visit their infant in the
NICU. They will have access to a pump while visiting in the NICU and lactation
consultant will help to arrange for a pump to use at home. They will be provided
containers to collect breast milk at home to bring in when they visit their baby in
the NICU. Once weekly the mother will collect the previous 24 hours supply of
breast milk, which will be homogenized and a sample taken for analysis. The
sample will then be analyzed for composition using the Miris human milk analyzer
for the carbohydrate, fat, and protein content and caloric density. The remainder of
 
If this field is not completed your
protocol will not be reviewed. Do
not enter N/A. Please describe
what methods and procedures
will be involved in this research.

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the milk will be stored as a batch and labelled to feed the infant when he/she is
ready.  
In the NICU a work area has been identified which has a sink, storage area, and
work surface. The work surface will be cleansed with a sterilization cloth, followed
by handwashing and then retrieving the milk from the refrigerator using universal
precautions. The 24 hour supply will be mixed into one clean mixing bottle large
enough to accommodate the entire 24 hours supply. It will be homogenized by
inverting the bottle 10 times. A 10 ml aliquot of the sample will be transferred into
a container labeled with subject number and taken for analysis. The remainder of
the milk will be repackaged into containers and labeled as one batch. The Miris
human milk analyzer is a mid infrared that reports the amount of energy absorbed
at each wavelength. The amount of fat (grams), lactose (grams), total protein
(grams), true protein (grams), and energy (kcal) per 100 ml will be reported. The
milk will be then fortified per protocol (control group), or with targeted fortification
(intervention group) as described above.  
In the NICU infants are weighed on a daily basis, as clinical condition allows;
weekly head circumference, length, and either flank skin fold or mid upper arm
circumference (dependent on weight). As standard of care infants <1500 g at birth
have a PEAPOD measurement prior to discharge to evaluate body composition. The
measurements will be performed by nursing staff on routine basis and will not be
blinded to the group assignment, as the bedside nurse will also likely be assisting
in preparing the feeds for the infant. The Peapod assessment is performed by CRU
staff as standard of care for these patients prior to discharge, they will be blinded
to the group assignment but the NICU staff (nursing, nurse practitioner, or fellow)
accompanying the patient to the measurement will not be blinded.  
 
 
 
8.5
Does this study only involve the use of existing/retrospective
data/specimens? 
No
 
Check yes or no.
 
8.6 
Describe in detail the study design also known as the experimental flow.
Include all study procedures a subject will go through, in order of
sequence and timing, including frequency of visits, duration of visits,
length of subject participation etc. Please Note this needs to be written for
an educated person who is not an expert in the field, do not exceed 300
words: 
- Infants with birth weight <1500g born at MetroHealth will be identified and are
eligible for this study if they meet inclusion and exclusion criteria. Mothers of these
infants will be approached for recruitment and included if they consent to
participate 
- As standard NICU procedure these infants will be started on total parenteral
nutrition (TPN) with SMOF lipids, and delayed initiation of enteral feeds determined
by birth weight and NICU guideline 
- The infant will be randomized to the standard fortification group (control) or
targeted fortification group (intervention). 
o Standard fortification group (control) 
 Breast milk will be fortified standard with Similac Human Milk Fortifier 1 packet:
50 ml breast milk at 50ml/kg/day enteral feeds, then 1 packet:25 ml breast milk at
75 ml/kg/day  
 As feedings are advanced to goal of 150 ml/kg/day, the TPN and SMOF lipids will
be decreased per standard management and NICU guidelines  
o Targeted fortification group (intervention) 
 Breast milk will be fortified standard with Similac Human Milk Fortifier 1 packet:
50 ml breast milk at 50ml/kg/day enteral feeds, then 1 packet:25 ml breast milk at
75 ml/kg/day  
 During this time, as the volume decreases, the TPN and SMOF lipids will be
optimized to provide a goal of 4 g/kg/day of protein, and 100-130kcal/kg/day 
 At 100 ml/kg/day of enteral feeds additional liquid protein and/or microlipids will
be added to the breast milk to provide goal of 4 g/kg/day of protein and 100-130
kcal/kg/day. This will be determined by analysis of the milk and reported
composition. 
 They will continue targeted fortification for 4 weeks after achieving full feeds of
150 ml/kg/day 
- Breast milk analysis will occur on a weekly basis immediately after birth for all
infants enrolled in the study.  
- Mothers collect a 24hr supply of breast milk once per week, from which a study
team member will obtain a 10 ml representative sample for analysis. The 24hr
collection of breast milk will be mixed into a clean container that can accommodate
the entire volume. It will be homogenized and a 10 ml sample removed for
 
This is also known as NIH
Experimental Procedure
section or Clinical Trial
Procedure/Experimental
Flow section. Do not just
attach documents in
response to this question you
must do a study design
summary for IRB Review.

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analysis. The remaining breast milk will be repackaged and placed back into the
refrigerator in the NICU. 
- After analysis, the milk for the following 1 week will be labeled and batched
together  
- For donor breast milk, each ‘lot’ will be analyzed and labeled for future use 
- Analysis will take place at MetroHealth in the lab, using the Miris human milk
analyzer. The amount of fat (grams), lactose (grams), total protein (grams), true
protein (grams), and energy (kcal) per 100 ml will be reported and used for
calculations. 
- Infants will have birth measurements obtained, daily weight, weekly
anthropometric measurements, and body composition measurement prior to
discharge. The measurements will take a few minutes to obtain on routine basis
per NICU protocol. The Peapod (body composition) measurement will take
approximately 20 minutes total traveling from the NICU to CRU and back, but the
actual assessment takes 2-3 minutes. This will be done with the infant is medically
stable and approaching discharge. 
 
The subjects will be in the study from time of consent to 4 weeks following the
achievement of full enteral feedings, which may range from 6 weeks to 12 weeks
depending on the birth weight and the clinical status of the infant. The smallest
babies will take the longest to increase to full feeds due to the slow feeding
protocol.  
 
8.7 
 
Please attach study design/subject visit schedule here: 
Name
Description
There are no items to display
 
If you have an
electronic schedule of study
visits and/or procedures please
attach here.
View: 09-00 Inclusion/Exclusion Criteria
 
9.0 Inclusion/Exclusion Criteria:
 
9.1 
What are the inclusion criteria? Put this information in bullet form: 
Premature infants <1500 g 
Mother consenting to provide breast milk or use of donor breast milk
 
Please list inclusion criteria.
 
9.2
What are exclusion criteria? Put this information in bullet form: 
Infants with major congenital malformations  
Infants with medical conditions precluding them from having breast milk  
Mothers with medical conditions that preclude them form providing breast
milk 
Insufficient breast milk supply 
Refusal of donor breast milk
 
Please list exclusion criteria.
 
9.3 
How will subject eligibility be determined and by whom? 
The principal investigator and co-investigators will determine subject eligibility
based on birth weight, inclusion, and exclusion criteria.
 
Please describe in detail.
 
9.4
Will you exclude women and minorities, or persons under 21 from
enrollment? 
No  
 
Check yes or no.
 
9.5
If yes, which groups are you excluding? Provide justification for your
decision. 
 
List groups to be excluded then
provide justification.
 
 
9.6
Attach Documents: 
Name
Description
There are no items to display
 
If you are unable to fit your
answers in the text boxes
provided please attach as a
word document.
View: 10-00 Risk/Benefits
 
10.0 Assessment of Risk I:
 
10.1
Identify and distinguish between those procedures that are standard
versus those that are experimental. Include the frequency and duration of
each activity and the total length of subject participation: 
Standard procedures: Pumping and providing expressed breast milk,
documentation of baby demographics, weekly anthropometric measurements,
PEAPOD prior to discharge, Metrohealth standard feeding protocol. 
 
 
Please distinguish between
those procedures that are
standard versus those that are
experimental. Describe in detail
all experimental procedures.

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Experimental procedure: Weekly analysis of small aliquot of breast milk with Miris
mid infrared human milk analyzer, targeted fortification of breast milk to achieve
protein goal of 4g/kg/day and calories 100-130 kcal/kg/day, fortification of breast
milk specifically for each mother/infant.  
 
Deviation from standard Metrohealth NICU practice: collection of 24 hour supply of
breast milk, analysis of breast milk content, targeted individualized addition of
protein and fat. All other procedures are the standard of practice in NICU.  
 
The measurements will take a few minutes to obtain on routine basis per NICU
protocol. The Peapod (body composition) measurement will take approximately 20
minutes total traveling from the NICU to CRU and back, but the actual assessment
takes 2-3 minutes. This will be done with the infant is medically stable and
approaching discharge. Analysis of the breast milk will take approximately 20
minutes per sample, including the time to prepare the sample for analysis and
analysis using the Miris human milk analyzer.  
 
The subjects will be in the study from time of consent to 4 weeks following the
achievement of full enteral feedings, which may range from 6 weeks to 12 weeks
depending on the birth weight and the clinical status of the infant. The smallest
babies will take the longest to increase to full feeds due to the slow feeding
protocol.
 
10.2
Describe any therapeutic alternatives to the research that may exist. How
are they different from those procedures that subjects would normally
undergo?  
Therapeutic alternative is standard fortification of breast milk per
protocol. This uses reported average protein and caloric content of breast
milk and adds standard amounts of fortifier. Content of breast milk is
variable between mothers and has wide range. They also have the option
to not participate in the study and receive standard NICU management.
 
Describe any therapeutic
alternatives. Can subjects
receive this drug or device
outside of a research study?  
 
10.3 
  
What are the outcome variables and how will they be analyzed? What are
the statistical and analytical methods that will be used? Note this section
can be copied from the NIH Grant Application or from the Statistical and
Analytical Methods section of the industry trial protocol. 
The outcome variables are the anthropometric measurements including daily
weight; weekly length, head circumference, skin fold thickness or mid upper arm
circumference; and PEAPOD body composition measurements prior to discharge.  
 
Our primary outcome is body composition, as measured by air displacement
plethysmography (PEAPod). As standardized assessment of body composition is
relatively new in the preterm infant population, we are using clinical judgment to
determine that a difference in fat free mass z-score (from data from Norris T,
2019) of 0.5 is clinically significant. To detect a difference at alpha a=0.05 with
80% power, 25 infants per group are required. This is a realistic goal for clinical
enrollment, due to the historical MetroHealth NICU census composition. According
to the census at MetroHealth, the total number of infants with birth weight less
than 1500 g for 2016 was 81 infants, and in 2017 was 84 infants. 
 
 
Define outcomes and describe
data analysis, please include a
power calculation.
 
 10.4
If the above requested information does not fit in the text box please
attach a word document here: 
Name
Description
There are no items to display
 
If the  requested information
does not fit in the text box
please attach a word
document.
View: 10-01 Risk/Benefits
 
10.1 Assessment of Risk II:
 
10.5
List and quantitate the risks involved for each experimental procedure in
bullet form. Identify risks as common (greater than 10%) uncommon
(greater than 1% up to and including 10 %) rare (1% or less). This must
match the risks listed in the Consent Form: 
Targeted fortification- rare, some babies may have elevated BUN which is
routinely monitored in the NICU, or rare, feeding intolerance  
 
There is also risk of breach of confidentiality, but this is rare. Data will be
stored securely, only key study investigators will have access to data, and
it will be deidentified and only the PI will have access to the key.  
 
The probability and magnitude of harm or discomfort anticipated in the
 
Select all that apply.

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research are no greater than those ordinarily encountered daily during
routine care while admitted to NICU. 
 
 
10.6 
Are there defined stopping rules?   
Yes 
No
What are the stopping rules for the study? What are the conditions under
which a subject will be withdrawn from the study for safety reasons, i.e.
disease progression? 
Intolerance to fortification, excessive emesis or recurrent, otherwise unexplained,
abdominal distention. 
What findings, events, or conditions would require a research subject to
be removed from the study? (i.e. disease progression) 
Clinical worsening, acute decompensation of infant precluding them from receiving
enteral feeds.  
If a patient become acutely ill and significantly decompensates they may be
removed from the study. Ex: sepsis, abdominal distention, blood in the stool,
respiratory failure with increasing need for respiratory support. If a patient
becomes comfort-care only and no longer receiving enteral feeds they may also
be removed from the study.  
 
Describe in enough detail for
the IRB to assess safety. 
 
10.7    
  
 
What Category of risk will study participants be exposed too?  
Name
Privacy
Other
 
 
 
Should be consistent with risks
listed in the Consent Form.
 
10.8
 
 
10.9
If Other listed above please specify: 
Infants will need to leave the NICU for PEAPOD body composition measurement.
This will be done once they are determined to be medically stable and ready for
discharge. 
Describe the availability of medical or psychological services that
participants might require as a consequence of participation in this the
research: 
The participants will have medical services available in the NICU at their disposal
during the entirety of involvement in the study. Every effort will be made to
obtain resources to support mother's pumping activities and providing of breast
milk- pumping room with breast pumps and supplies, lactation services, nutrition
services.
 
A text box is provided for
further explanation.
A text box is provided for
further explanation. 
 
10.10
Describe in detail any measures in place to minimize or protect against
the exposure of study subjects to these risks: 
Infants will be transferred to the research unit in an open crib one hour after
his/her regular feed. they will be placed on a warmer while heart rate, respiratory
rate, and pulse ox will be monitored continuously. The entirety of the assessment
will take about 20 minutes. After the PEAPOD is completed the infant will be
transferred back to the NICU.  
 
Data will be stored in a secure location to protect confidentiality.
 
Discuss any provisions for
intervention in the event of an
Adverse Event i.e. stopping
rules.
 
10.11
Please add any documents related to the above questions: 
Name
Description
There are no items to display
 
If your answers to the above
questions are too long for the
space provided please attach
them here. 
View: 10-02 Risk/Benefits
 
10.2   Benefits:
 
10.12 
Describe the potential benefits to the subject as a result of participating
in this research. If there is no direct benefit to subjects please state that
as well: Note: payment or compensation to subjects for participation is
not to be considered a potential benefit. 
Receiving targeted fortification may result in improved growth and body
composition with more lean body mass. Improved neonatal growth may have
 
Describe potential benefits to
the study subjects.

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impact on improved long term medical outcomes, with decreased susceptibility to
infections, and also neurodevelopmental outcomes.
 
10.13
Describe the potential benefits to society as result of this research: 
Care of premature infants has a large financial and emotional impact on
parents and society, even after discharge from the NICU. They are high
risk patients that may require frequent readmissions to the hospital with
illnesses. Optimizing growth and nutrition of premature infants is
associated with decreased morbidity and improved outcomes.  
 
If a significant difference can be shown in the study group, having a milk
analyzer in all NICUs and targeted fortification of breast milk to provide
optimal nutrition can become standard of care. This has the potential to
reduce the burden on the health care systems taking care of these
patients.
 
Describe potential benefits to
society.
 
10.14 
What is the risk/benefit ratio of the research? 
In this research, infants are given additional protein and fat targeted to their
mother's breast milk composition and their nutritional needs, which alone does not
have any potential risk. The benefit of improved growth is significant with overall
improved medical and neurodevelopmental outcomes. Potential benefits outweigh
the risk of participation.
 
Discuss why the risks are
reasonable in relation to the
anticipated benefits. 
 
10.15
Attach Documents: 
Name
Description
There are no items to display
 
Attach documents here. 
View: 11-00 Study Participant Information I
 
 
11.0 Study Participant Information I:
 
11.1 
 
 
 
11.2 
How will the Principal Investigator assure he/she has access to a
population that would allow recruitment of the required number of study
participants (i.e. prep for research): 
Based on MetroHealth Medical Center NICU statistics, there are approximately 80
babies weighing less than 1500 grams admitted every ear.  
 
The accrual numbers in 11.2 represent mother/baby couples.
Anticipated number of subjects (all sites): [enter a number] 
60
Anticipated number of subjects to be enrolled at MHS: [enter a number] 
60
Anticipated number of potential subjects to be approached: [enter a
number] 
60
 
How does the PI know he/she
has the required number of
subjects?
Please give the total #of
subjects to be enrolled at all
sites and anticipated subjects
to be enrolled at MHS.   
 
11.3
If this is a multi-site study, how many sites will there be? [enter a
number] 
 
 
How many total sites?
 
11.4 
Subject Characteristics: 
Subject Population Categories
Inpatients
 
Check all that apply
 
11.5
 
 
 
 
 
Subject Source: 
Subject Source Characteristics
Other
 
Check all that apply

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11.6
If "other" list above in either 11.4 or 11.5 please describe: 
Infants delivered at MHMC with birth weight less than 1500 grams on admission to
NICU.
 
 
 
If applicable please describe. 
 
 
View: 12-00 Study Participant Information II
 
12.0  Study Participant Information II:
 
12.1 
Select age range of study participants: 
Subject Age Range
0 - 6
12 - 17
18 - 64
 
Check all that apply. 
 
12.2
* Will the study enroll vulnerable subject groups? 
Yes
* Will you be enrolling Children? 
  
Yes 
No
* Will you be enrolling Pregnant Women and/or Fetuses? 
  
Yes 
No
* Will you be enrolling decisionally impaired subjects? 
  
Yes 
No
* Will you be enrolling Prisoners?   
Yes 
No
 
Check yes or no.
 
12.3 
Please identify any vulnerable populations participating in the study: 
Vulnerable Populations
Poor / Uninsured
Minors - Children under 18
Employees
Students
Minorities
 
Check all that apply.
 
12.4
 
12.5
If you selected "other" above please describe: 
If you are going to enroll any vulnerable populations please describe the
safeguards you will put in place to protect these vulnerable Populations.  
Informed consent will be obtained from the mother prior to enrollment of the
premature infant. They will be informed that participation in the study is optional
and their decision will not impact the medical care that the infant receives. 
 
 
Please describe other.
Please enter a detailed plan.
 
View: Supplemental Review Form for Research with Children I
 
Supplemental Review Form for Research with Children I:
Federal regulations require the IRB to provide additional protections for children involved as subjects in research. There are four categories of
permissible research that involve children [45 CFR 46.404, 46.405, 46.406, or 46.407]. Please complete each section as it applies to your
research. Each question must be fully answered, or your study will be returned and IRB review will be delayed.
ASSESSING RISKS AND BENEFITS
When assessing risks and benefits, consider the variability in health status of the subjects to be enrolled, their medical
experiences, and the extent to which the research procedures will be a burden to the subjects in the context of their daily lives
and/or routine medical care. Be sensitive to how a procedure that generally entails little to no physical or psychosocial risks
may affect someone with limited (or no) understanding of the situation. Procedures that usually present no more than minimal
risk to a healthy child include: physical exam, ultrasound, urinalysis, obtaining a small amount of blood, EEGs, allergy scratch

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tests, minor changes in diet or daily routine, and/or the use of standard psychological or educational tests. The assessment of
the probability and magnitude of the risk, however, may be different in sick children and may vary depending on the diseases
or conditions the subjects may have.
Minimal Risk: As defined in the regulations 45 CFR 46.102(i), “minimal risk" means the probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests.”
Answer 1, 2, 3, or 4 below if applicable:
 
1. 
 
 
Is this Pediatric Research not involving greater than minimal risk (see definition above) [45 CFR 46.404]:
  
Yes 
No
Explain Why you think this study is not greater than minimal risk: 
We will be fortifying breast milk with protein and fat to provide individualized nutrition based on human milk analysis
to meet nutritional goals and optimize premature infants growth. We will be using liquid protein and microlipids which
are approved for neonatal use. Optimizing nutrition will potentially have a beneficial effet on growth, medical, and
developmental outcomes.  
No medications or other potential harmful substances are given. The probability and magnitude of harm or discomfort
anticipated in the research are not greater than those ordinarily encountered in daily life or during routine care in the
NICU.
*************
 
 
2. 
 
 
 
 
 
 
 
 
 
 
  
 
Is this Pediatric Research involving greater than minimal risk but presenting the prospect of direct
benefit to individual subjects [45 CFR 46.405]. Answer all questions below.   
Yes 
No
Explain why you think the procedures or interventions are of greater than minimal risk: 
Describe the anticipated or possible health benefits, and explain why you think the study interventions or
procedures hold out the prospect of direct benefit to each individual subject: 
Explain why you think the risk to subjects is justified by the anticipated benefit: 
Explain why you think the risk/benefit ratio is at least as favorable to the subjects as that presented by
available alternative approaches:  
 **************
 
 
 3. 
 
 
  
 
 
 
  
 
 
 
Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but
likely to yield generalizable knowledge about the subject’s disorder or condition. [45 CFR 46.406].
Answer all questions below: 
  
Yes 
No
Explain why you think the interventions or procedures represent no more than a minor increase over
minimal risk:  
Explain why you think the interventions or procedures present experiences to subjects that are
reasonably commensurate with those inherent in their actual or expected medical, dental, psychological,
social, or educational situations: 
Explain why you think the interventions or procedures are likely to yield generalizable knowledge about
the subjects’ disorder or condition that is of vital importance for the understanding or amelioration of the
subjects’ disorder or condition: 
**************
 

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  4.
 
 
 
  
 
Is this Pediatric research that is, not otherwise approvable that presents an opportunity to understand,
prevent, or alleviate a serious problem affecting the health or welfare of children [45 CFR 46.407]. This
category includes research that does not meet the criteria for any of the above three risk/benefit
categories. Research in this category represents more than a minor increase over minimal risk and no
prospect of direct benefit to subjects. 
  
Yes 
No
Explain why you think the research presents a reasonable opportunity to further the understanding,
prevention, or alleviation of a serious problem affecting the health or welfare of children: 
NOTE: This kind of research requires review by the Secretary of DHHS, after consultation witha panel of experts in
pertinent disciplines, and public review and comment. Contact the Manager and Chair of the MHS IRB at 216-778-
2077, if you believe your research falls into this category.
 
View: Supplemental Review Form for Research with Children II
 
Supplemental Review Form for Research with Children II:
SECTION 2: PERMISSION OF PARENTS/GUARDIANS AND ASSENT OF CHILDREN
 
 5. 
Permission of Parents or Guardian (check one below)
  The permission of both parents or a guardian(s) will be sought unless one parent is
deceased, unknown, incompetent, or not reasonably available, or when only one parent
has legal responsibility for the care and custody of the child (required for categories
45CFR.406 & 407 see questions [3] and [4] ).
or
  The permission of only one parent will be sought (acceptable for categories 45CFR46.
404 & 405 see questions [1] and [2]).
 
 
INSTRUCTIONS: Check
all that apply and answer the
related questions.
 
 
  6.
Assent of Children (check one below)
  The assent of each child who is capable of providing assent based on age, maturity,
and psychological state will be sought.
or
  The assent of each child will not be sought because the capability of all of the children
in this study population is so limited that they cannot reasonably be consulted.
Explain why the capacity is so limited, e.g., age, maturity and/or psychological state: 
Age- premature infants, from birth until hospital discharge approximately 3-4months old
or
  The assent of each child will not be sought because the intervention or procedure
involved in the research holds out a prospect of direct benefit that is important to the
health or well-being of the children and is available only in the context of the research.
Explain what the direct benefit may be and why it is only available in the context of the
research: 
NOTE: Ohio law generally permits individuals to consent for their own medical care at age
18, but limited exceptions permit individuals to consent at an earlier age to certain
treatments. Consult the MHS Policy I-34 on the MIV.
View: 13-00 Recruitment I

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13.0  Recruitment I:
All external advertisements (for radio, print media or TV) must be approved by MHS Communications
Department prior to submission to the IRB so the IRB can see the final advertisement or script. All
Advertisements on the MIV or On Hold messaging must be approved by the IRB before they are placed.
You may not advertise a study which is not approved by the IRB. Please note that all studies which have
a contract which an external sponsor must have that contract signed before any advertising can be done.
 
13.1 
Recruitment Methods/Sources: 
Name
None
 
Check all that apply. 
  
 
13.2
If "Other" checked in 13.1 please explain: 
 
Please explain what other
means.
 
13.3 
Describe in detail all recruitment strategies for each subject group (as
listed in Section 11.0) selected for this research:  
Recruitment is from all deliveries at MHMC with birth weight less than 1500 grams.
The NICU admission log will be consulted. Mothers of infants fulfilling the inclusion
criteria will be approached and informed consent will be obtained for enrollment
into the study. Mothers will be approached while in labor and delivery once they are
stable or when they visit the infant in the NICU and able to comprehend the
informed consent process.
 
Please describe recruitment
strategies in detail.
 
13.4
What measures will be taken during the recruitment process to safeguard
against the potential coercion or appearance of coercion of human
subjects, particularly vulnerable subject groups?  
Mothers will be given ample time to read and review the informed consent and
discuss with close family and friends. They will also be told that participation in the
study is not required and it will not impact their care.
 
Please give an explanation of
safeguards to be used.
 
13.5
Incentives to Subjects: Will subjects receive any incentives (payments,
free service, gifts, etc.) for participation in the research? 
No
 
This information must mirror
the consent form language.
 
 
 13.6
If yes, please describe these incentives and how they will be disbursed:
Note: payment or compensation to subjects for participation is not to be
considered a potential benefit. 
 
Describe incentives, if they are
to be pro-rated based on visits
completed please give that
information. This information
must mirror consent form
language.
 
 
13.7
Please attach copies of all recruitment/advertising materials and verbal
scripts:  
Name
Version
There are no items to display
 
Attach copies of all recruitment
and advertising materials.
View: 13-01 Recruitment II
 
13.1  Recruitment II:
 
13.8 
Expense to Subjects: Will subjects incur any expenses as a result of
participation in the study or will they be billed for any study-related
procedures? 
No  
 
Check yes or no, make sure
this information is in the
consent.
 
13.9
If yes, please describe the expenses or charges that subjects will be
assessed: 
 
Please provide information
regarding expenses to subjects
and add information to
consent.   
 
13.10 
Compensation For Injury: If applicable, will funding be available to
compensate subjects for injuries sustained as a result of participation in
 
Check yes or no, make sure
this information is in the
consent.  

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this research? 
No  
 
13.11
Who will cover the costs related to any injuries sustained due to
participation in the study? 
 
Please describe in detail.
Examples subjects or their
insurance company, study 
sponsor.
View: 14-00 Data Collection
 
14.0 Data Collection:
 
14.1 
A. What type of data will you be collecting as part of this research?
 
Will you collect existing data? 
 
or
Will you collect prospective data? 
  
Yes 
No
or                                 
Will you collect both existing and prospective data?   
Yes 
No
Definitions: Data are considered to be existing data only if they were in
place or "on the shelf" prior to the submission of the research protocol to
the IRB.  Data are considered prospective if they are created and collected
as part of the research i.e. from surveys, questionnaires. 
B. Why are you collecting this data?
What will be the purpose of collecting and/or reviewing the data (new
data or existing data). 
After intervention of targeted fortification vs standard fortification anthropometric
measurements and body composition will be measured. Daily weight; weekly
length, head circumference, skinfold thickness or mid upper arm circumference;
and PEAPOD body composition prior to discharge. These will be measured to
evaluate growth parameters of infants receiving individualized targeted fortification
to meet nutritional goals vs standard fortification.
 
 
Existing data must be in place
or on the shelf prior to the
submission of the research
protocol to the IRB.
Prospective data is collected in
real time.
 
 
 
 
Tell the IRB why you are
collecting this data i.e. to verify
inclusion criteria.
 
14.2
If you are collecting existing data:
Specify the type(s) of existing data sources you will use (medical records,
school records, publicly available records, existing database). If you are
collecting data from an exisitng database and that database contains PHI,
you must provide the IRB Approval letter (attach to Section 27.00
Additional Documents). 
We will use medical records for mother and baby to obtain demographics.
What is the timeframe of the existing data you wish to review? (i.e. 2000-
2006) 
Any time before study enrollment.
 
Specify the types of existing
data you will use in this study. 
 
 
Time frame i.e. last 10 years or
from 1990-2000.
 
14.3 
If you are collecting prospective data:
Where or how will the data be obtained? (i.e. surveys, questionnaires,
psychological tests) 
NICU admission log and electronic medical records. Milk samples will be analyzed
in the lab at MHMC using the Miris human milk analyzer. PEAPOD body composition
measurements will be done at the CRU.
 
 
Where will data
be obtained? i.e. survey.
 
14.4
How will the data you collect be identified?
 
 

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Types of Data Identification: 
Name
Deidentified/Confidential- Data will be linked to subject(s) via a code or indirect
identifier (i.e. study IDs or numbers)
Please select how your subject
data will be identified.
 
14.5
 
 
14.6 
 
 
Will the information collected from these records be linked to any research
subjects by identifiers? (i.e. name, MRN#, DOB) 
  
Yes 
No
Please answer questions about the security of the data in section 15.00
If subject data will be deindentified using a code will there be a link or
a key? Please describe. Who will have the key and where will the key be
kept?  
Each patient in the database will be assigned a sequential subject number. Medical
record number will be in the key only, not I the database. The key will be kept in
REDCap and the deidentified data will be kept on a secure MHS network drive. Only
the PI and coinvestigator will have access to the key.
Under the HIPAA Regulations, deidentified key codes must be stores
separately from data & must not be kept on paper, but electronically.
The MetroHealth Research Informatics Support should be contacted at
REDcap@metrohealth.org for assistance. They will assist personnel in
developing a key in MetroHealth REDcap database. They can also
assist with training & development for your study. REDcap is a free
database provided in part by the Case CTSA.
 
 
Will your data be linked to
subjects?
 
 
Explain how Data will be
linked. 
 
 
14.7
Data Collection Form(s): 
Name
Version
data sheet HMA revised.xlsx | History
0.01
 
Add data collection forms and
CRFs.
        
View: 15-00 Data Security I
 
15.0 Data Security I:
It is imperative that the IRB is proactive and consistent in protecting all research data containing Protected
Health Information(PHI).
15.1 * Are the records for this study (some or all) electronic?   
Yes 
No
What is Protected Health Information? The Privacy Rule protects certain information that covered entities use and
disclose. This information is called protected health information (PHI), which is generally individually identifiable
health information that is transmitted by, or maintained in, electronic media or any other form or medium. This
information must relate to 1) the past, present, or future physical or mental health, or condition of an individual;
2) provision of health care to an individual; or 3) payment for the provision of health care to an individual. If the
information identifies or provides a reasonable basis to believe it can be used to identify an individual, it is
considered individually identifiable health information.
The following questions must be answered when submitting a new protocol. 
15.2       * Are you collecting PHI?   
Yes 
No            
15.3       Is any PHI going to be stored as paper files?   
Yes 
No
15.4       Is any PHI going to be stored in an electronic file format? (i.e. access, excel)   
Yes 
No
15.5       Is your data being stored on a laptop computer?   
Yes 
No
15.6       Will you be using RedCap to store your data?   
Yes 
No
               Which RedCap Database will you be using? 
Name

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Name
MetroHealth
15.7       Are you planning to store your data using a portable storage device?(i.e. jump drive, external hard drive,
cd)   
Yes 
No
               *Per current MetroHealth Policy PHI may not be stored on portable electronic devices. 
15.8       Are there any circumstances under which you would want to remove data from MHS? (i.e. take data home
to work on it) Give details below. Please note identified data can't be removed from MHS unless there is
permission granted in the HIPAA Authorization. If you are unsure about what is identified data please consult the
IRB staff. If you feel you will need access to your data when you are off campus you should ask the MHS
IT Department located in Rammelkamp room R 134 about VPN access.   
  
Yes 
No
               If you answered yes to question 15.8, please explain? 
        
 
15.9
Where will the records pertaining to this research be stored? (give the
actual physical location of the paper records i.e building name and room
number); and/or the secure network drive where the data is being
stored. 
Records will be stored electronically on the shared secure network drive of the
MetroHealth network.  
 
REDCap(Research ElectronicData Capture) is a secure, web application designed
to support data capture for research studies, providing user-friendly web-based
case report forms, real-time data entry validation (e.g. for data types and range
checks), audit trails and a de-identified data export mechanism to common
statistical packages (SPSS, SAS, Stata, R/S-Plus). The system was developed by
a multi-institutional consortium which includes The MetroHealth Medical Center
and was initiated at Vanderbilt University. The database is hosted at the
MetroHealth Datacenter. The system is protected behind a login and The
MetroHealth Firewall. There is an audit trail tracking all logins and activities in
the database. Data collection is customized for each study or clinical trial based
on a study-specific data dictionary defined by the research team with guidance
from the REDCap administrator. 
 
State the exact physical
location of paper files and the
network drive for electronic
files. 
  
 
15.10
How will these records be secured (we are refering to both paper
records and electronic records)? Examples for electronic records (i.e.
secure drive, password protected documents, encrypted jump drive).
Examples for paper records, must be double locked (i.e. locked office
and locked file cabinet or a locked file box inside a locked cabinet). 
Records will be stored electronically on the shared secure network drive of the
MetroHealth network, which will require a password to retrieve which only the
study team will have access to. Only the study team will have access to REDcap,
which will require a password to access.
 
i.e. locked cabinet, locked
room.
 
15.11    
Who will have access to the data? 
Principal investigator and co-investigators listed.
Please Note: All study documents must be retained for a minimum of four years
after study completion (even when no subjects have been enrolled), twenty-two
years if study involves children or pregnant women. Records for device studies
must not be assigned a destruction date until the FDA approval status is
determined, at which point records will be retained according to the scheme
above (minimum of four or twenty-two years as appropriate). Under HIPAA
regulations you must keep a record of all medical records where you looked at or
recorded PHI (without a HIPAA Authorization) for 6 years (i.e. prep for
research).
MHS Record Retention Policy VII-4
 
Give name and title exclude
study staff who are MHS
employees.
 
15.12
 
How long will you keep the records pertaining to this research? Where
will these records be stored after the study has been completed?  
Records will be kept for 22 years after the end of the study in a password
protected secure MHS drive.
 
Check the MHS Record
retention policy for guidance.

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15.13
Where, when, and how will the information be destroyed? 
The electronic records will be deleted in consultation with IS 22 years after study
completion.
*Please Note: There are EPA regulations surrounding the destruction of
CDs, DVDs, Floppy discs and other portable storage media. If you want
to destroy these types of media please contact Ron Wallace in
Environmental Services at 778-4776. 
 
 
 
 
You must have a plan for data
destruction.
View: 15-01 Data Security II
 
15.1 Data Security II:
 
15.14
 
 
Who (non-study staff) will have access to the records? Give name and
title of individuals. Where an individual's name is not known give title i.e.
monitor from CRO. 
NA
 
List all those not study staff
who will see and have access
to data.
 
15.15
Will data be transmitted to the sponsor?   
Yes 
No  
 
Are you sending CRFs to
sponsor?
 
15.16
 
If yes, describe what data will be sent to the sponsor and the provisions
that have been made for preservation of confidentiality in the
transmission of data to the sponsor: 
 
Please describe i.e. will you be
using encryption software?
 
15.17
Will the data from this research project be transmitted to anyone other
than the sponsor?   
Yes 
No
 
Check yes or no.
 
15.18 
If yes, to whom will this data be transmitted? 
 
Please describe organization or
individual.
 
15.19
Describe the data that will be sent to entities other than the sponsor and
what provisions have been made for the preservation of confidentiality: 
 
Please describe data, and
confidentiality provisions.
View: 16-00 Request for a Partial Waiver of HIPAA Authorization
 
16.00 Request For a Partial Wavier of HIPAA Authorization
An IRB, under certain circumstances, may allow researchers to forgo obtaining an authorization; this is called a waiver of authorization. A
waiver of authorization may be full or partial:
full waiver: an IRB waives the requirement for authorization for all uses of PHI for a particular research protocol (see Section 16.01
Request for a Waiver of HIPAA Authorization);
partial waiver: an IRB waives the requirement for an authorization only for some uses of PHI for a particular research protocol.
Researchers are required to obtain subjects' Research Authorizations after recruiting and enrolling subjects via a partial waiver and prior
to creating or using PHI during research procedures.
Partial Waiver for Preparatory for Research Activities:
According to HHS guidance on the Privacy Rule the preparatory to research provision permits covered entities to use or disclose
protected health information for purposes preparatory to research, such as to aid study recruitment. However, the provision at 45
CFR 164.512(i)(1)(ii) does not permit the researcher to remove protected health information from the covered entity's site.
As such, a researcher who is an employee or a member of the covered entity's workforce could use protected health information to
contact prospective research subjects. The preparatory research provision would allow such a researcher to identify prospective
research participants for purposes of seeking their Authorization to use or disclose protected health information for a research
study.
Under the preparatory to research provision, a covered entity may permit a researcher who works for that covered entity to use PHI
for purposes preparatory to research. A covered entity may also permit, as a disclosure of PHI, a researcher who is not a workforce

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member of that covered entity to review PHI (within that covered entity) for purposes preparatory to research.
 
 
16.1 
Are you requesting a Partial Waiver of HIPAA Authorization?   
Yes 
No
Why are you requesting a Partial Waviver?
 
Check yes or no. 
 
16.2
Is the purpose of the Partial Waiver Recruitment (including screening of Medical
Records)? 
  
Yes 
No
Is the purpose of the Partial Waiver to request access to PHI for Non-MetroHealth
personnel? 
  
Yes 
No 
 
Check yes or no.  
 
16.3 
Will the use of Protected Health Information (PHI) involve more than minimal risk to
the privacy of the patients? 
  
Yes 
No
 
Check yes or no.  
 
16.4
The IRB as part of it's review of this request must have certain reassurances that
Patient Privacy will be protected, please respond to the following questions true or
false.
1.) The PHI will be used solely to facilitate the research protocol as an aid to study
recruitment or to expand the research study. The waiver would allow identification
of prospective research participants for the purpose of seeking authorization to use
or disclose PHI for a research study. Essentially, PHI will be used to identify and
contact potential research participants. Only contact and screening information
(race, age, medications, diagnosis, and primary physician) will be recorded, and no
information will leave the premises of MetroHealth Medical Center. The information
will not be disclosed outside the research group for this study.   
True 
False
2.) Information about potential subjects who are not interested in participating will
be destroyed after the patient declines enrollment. The information of patients
choosing to participate will be further used to schedule an appointment. As soon as
the research staff sees the participant, a full authorization will be obtained to
collect, use and disclose PHI for the remainder of the study.   
True 
False
3.) The PHI will not be reused or disclosed. Because the PHI belongs to individuals
who are not yet in the study, oversight provisions do not apply. After subjects are
formally enrolled, an authorization will be in effect and the waiver will no longer
apply.   
True 
False
 
Check true or false. 
 
 
 
16.5
If you did not answer true to all three parts of question 16.4 please explain: 
 
Please explain your response
to any statement where you
have entered false.
 
16.6
Please give a detailed explanation as to why this research activity cannot be
practicably conducted without a Partial Waiver or without access to PHI: 
Prospective study subjects from the inborn deliveries at MHMC will be identified
based on inclusion criteria, evaluated with access to PHI.
 
Example: our study
population has xxx disease
and we rely on the EMR
information to identify and
contact potential subjects.
 
16.7
Who will have access to PHI? Please list below: 
Name
Employer
Department
Employer Name
Sharon Groh-Wargo MHS
Pediatrics
The MetroHealth System
Stephanie Merlino
MetroHealth Neonatal
The MetroHealth System
Stacey Ramey
MetroHealth Pediatrics, Neonatology The MetroHealth System
 
Add the names of persons who
will have access to PHI. 
 
16.8
Are you or anyone who assists you Non-MetroHealth Personnel?   
Yes 
No
*Note all Non-MetroHealth Personnel have to go through employee orientation,
have a security clearance and Epic training before they can access the MetroHealth
 
Check yes or no. 
 

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EMR. Also all all Non-MetroHealth Personnel must work under the control of a
member of the MetroHealth Staff.
 If you have previously completed an MHS Prep for Research form add that form
here:  
Name
Version
There are no items to display
Old Memos Requesting Partial Waivers (prior to 11/26/2010):
There are no items to display
If you filed a Prep for research
form with IT and RABO please
attach it here.
Partial Wavier Memos
completed prior to 11/26/2010
will populate here.
 
View: 16-01 Request for a HIPAA Waiver of Authorization
 
16.1 Request For a HIPAA Waiver of Authorization:
 
16.9 
Are you requesting a Waiver of HIPAA Authorization? 
No
Check one, if you check no then hit continue and go to the next page.
If you are requesting a Waiver In order for the IRB to Grant a Waiver you
must answer questions 16.10-16.16
 
 
Check yes or no.
 
16.10
Disclosure of Protected Health Information (PHI) will not involve more
than minimal risk to the privacy of the patients/subjects: 
 
Check true or false.
 
16.11 
What is the plan to protect patient/subject identifiers from improper use
and disclosure? 
 
i.e. This unique identifier will
be used on the data collection
form. Only the PI will have
access to the key linking the
unique identifier to
patient/subject names. 
 
16.12
What is the plan to destroy the identifiers at the earliest opportunity
consistent with the conduct of the research? 
 
i.e. The unique identifier key
will be retained in Red Cap and
will be destroyed two years
after the study ends.
 
16.13
Will PHI be reused or disclosed to others:  
 
Check yes or no.
 
16.14
Please complete the following: Data will only be used to analyze... 
 
i.e. Data will only be used to
analyze...
 
16.15
Describe why this research can not be conducted without a waiver: 
 
i.e because many of the
subjects who participate in this
treatment are dead or have
transferred to other treatment
modalities, or are transient. To
obtain HIPAA Authorization
from these individuals would be
a greater risk to their loss of
privacy.
 
16.16
Describe why this research could not be conducted without access to and
use of PHI:  
 
i.e. It would not be possible to
determine linkages between
.......and clinical outcomes
without the use of PHI.
View: 16-02 HIPAA II
 
16.2 HIPAA II:
 
16.11
 
       
                      
Check all that apply, your answers
will help the IRB to determine if
your data is a limited data set.

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Which of the following identifiers about subjects will be
collected for this study?
 
Name
2. Telephone Numbers
8. Names or Initials
16. Medical record or prescription numbers
21. Dates (except year) related to an individual (birth date,
admission date, discharge date, date of death)
These Questions deal with the collection of data and data
use agreements. If you are not receiving data or sending
data out to another entity this does not apply to you. If you
have a signed contract with a sponsor or are in a
cooperative group that has a signed agreement with MHS
this does not apply to you. Data use agreements specify the
conditions under which data can be shared between MHS
and other organizations or individuals.
 
 16.12
If you have selected only numbers 4, 5, 6, or 22 in
question number 16.11 your research is considered to
use a limited data set. If either of the following
conditions apply, you will need to obtain a Data Use
Agreement and complete a waiver of authorization or
obtain a HIPAA authorization from the subjects. (check
one): 
Name
There are no items to display
Check one, please read
carefully if you are not
receiving data or sending data
out to another entity this does
not apply to you, move on to
16.14. If you have a contract
with a sponsor or you are in a
cooperative group that has a
signed agreement with MHS
this does not apply to you. In
all other cases please
contact the MHS Legal
Department with questions
about data use agreements.
 
16.13
Attach a copy of the Data Use Agreement: 
Name
Description
There are no items to display
 
Attach Data Use Agreement.
View: 16-03 HIPAA III
 
16.3 HIPAA III:
 
16.14 
If any other unique identifying number, characteristic or code is selected,
please specify: 
NA
 
Please specify this question
refers back to the list of 22
identifiers.
 
16.15
If a link to an identifier will be used (i.e. code numbers) is selected,
please describe the coding mechanism that will be used: 
As patients are enrolled into the study they will be assigned a study
number. Only the study staff will have access to the key.
 
Describe the coding
mechanism.
 
16.16 
Will a certificate of Confidentiality be obtained for this study? No  
 
Check yes or no. 
 
16.17
If yes, please attach a copy the Certificate of Confidentiality: 
Name
Version
There are no items to display
 
Attach a copy of the Certificate
of Confidentiality.
 
 16.18
Describe how you will protect the privacy of participants. Describe
specifically how you will gather information from or about them. Please
note while confidentiality concerns data, privacy concerns people.
Example People may be uncomfortable answering questions about their
employer in an open cubicle, so investigators may arrange for a more
private location. 
When approaching parents and speaking to them, the study staff will ensure that
this is done within a private location in NICU.  
Patients will be assigned a study number. The key will be kept in a private,
 
Please note while
confidentiality concerns data,
privacy concerns people.  

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secure location, that only the study staff will have access to. 
 
 
 
  
View: 17-00 Waiver of Informed Consent
 
17.0  Request for a Waiver or Alteration of Informed Consent:
             
 
 17.1
Are you requesting a Waiver of Consent [45 CFR 46.116(d)] OR a Waiver
of Documentation of Consent [45 CFR 46.117 (c)].  
No  
If no hit continue button and you will go to the next page.
If yes please Note:
Note: Waivers of consent are not applicable if the research is subject to
FDA regulations, except the following. 
 
FDA Exception from general requirements:
1. Emergency Ues: Waivers of Informed Consent in FDA-regulated studies are
permissible in case of life-threatening situations, inability to communicate,
not sufficient time and no alternative method, even if research presents
more than minimal risk [21CFR50.23];
2. Planned Emergency Research: If the study satisfies the requirements under
21CFR50.24 “Exception from Informed Consent Requirements for
Emergency Research.”
 
 
Answer yes or no.
 
17.2
Waiver of Consent: If you are requesting a waiver of consent, please
provide the justification and address each of the following points for the
IRB's consideration: 
 
 
This research study involves no more than minimal risk: 
 
The waiver will not adversely affect the rights and welfare of the subjects: 
 
 
This research could not practicably be carried out without a waiver:
Whenever appropriate, the subjects will be provided with additional
pertinent information after participation: 
  
Yes 
No
 
Check true or false.
 
Note: practicably does not
mean it would be inconvenient.
 
 
17.3 
Please explain your answers to the above questions (You must provide the
IRB with enough information to make a decision): 
An IRB may waive the requirement to obtain a signed consent form for some
or all subjects if it ﬁnds either of the condiƟons below. In cases in which the
documentaƟon requirement is waived, the IRB may require the invesƟgator to
provide subjects with a wriƩen statement regarding the research.
 
Please explain in detail.
 
17.4
 
 
17.5
(1) The only record linking the subject and the research would be the
consent document and the principal risk would be potential harm resulting
from a breach of confidentiality. Each subject will be asked whether the
subject wants documentation linking the subject with the research, and
the subject's wishes will govern; OR
 
Check true or false.
 
Check yes or no.

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(2) The research presents no more than minimal risk of harm to subjects and
involves no procedures for which wriƩen consent is normally required outside of
the research context.  
  
Yes 
No
 
17.6
If you are requesting any Alteration to the standard consent form/process
(written long form consent is the standard) please provide a detailed
explanation or plan.
 
 
Example of an alteration:
verbal consent.
View: 17-01 Informed Consent Process I
 
17.1  Informed Consent Process I:
 
17.7
Who will be approached to obtain consent/assent: 
Consent Method
Subjects will be asked to sign a study consent form after receiving a complete
explanation of the study.
Parents/Legal Guardian will be asked for permission after receiving a complete
explanation of the study.
 
Check all that apply.
 
 
 Idendtify all Staff obtaining consent on page 1 question 1.4 by selecting
the corresponding role.
 
 
 17.8
Subject Comprehension: What measures will be taken to ensure that
subjects fully understand the nature of their involvement in the research?
Note to Investigator: 
To address issues of comprehension on the part of the participant or
representative, and who is involved in obtaining consent, the answers to
following questions should be addressed:
1.)  Once a potential participant is identified, what process is
followed to inform the subject of the study prior to obtaining a
signature on the informed consent form?
a.    Who introduces the study to the potential subject?
b.    Who reviews the informed consent document in depth?
c.     Do you require the potential participant to have another person
present during the presentation of the study? 
2.)      Who answers the questions presented by the potential   
participant and/or family? 
3.)      What method is used to determine if the potential participant
fully understands the study, what is required from them, risk and
benefits, and their rights as a participant? 
4.)      Is the principal investigator usually present during the
presentation of the informed consent?
 
Potential mothers will be approached by a study team member and a detailed
explanation of the study will be given to them. A copy of the informed consent will
be given to the mother. they will be allowed time to read over the consent and
discuss it with family or close friends. they will be asked if they fully understand
the study, risk and benefits, what is required of them, and their rights as a
participant. One of the co-investigators will be present. The consent form will be in
English and it will be ensured that the participant understands English and can
read English.
 
Please give brief explaination.
 
 17.9
Capacity to Consent: How will capacity to consent be assessed? This
question is to be addressed for all subjects not just those with limited
decision making capacity. Identify who will make this assessment?
Suggested language....all subjects will be awake, alert and oriented, be
able to read etc. It is important to address issues like ability to read and
understand information in the consent.  
All subjects will be spoken to in English and it will be ensured that they
understand, speak, and can read the language. They will be approached with they
are awake, alert, and oriented and out of the effect of any sedating medications
given during delivery.
 
How will you determine
capacity to consent?

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 17.10
Attach a description of the Consent Process: Explain the process of
obtaining consent from subjects. Under what settings and conditions will
consent be obtained? What will be the timing/waiting period? What
measures will be taken to ensure that subjects will make decisions
independently? Note to Investigator:  The “informed consent process”
should include sufficient time for the participant to review and consider
participating with the assistance of family members, research partners or
representative if necessary.  Other items to consider regarding time / waiting
periods are:  Is the potential participant given a copy of the consent form to read
prior to the discussion of the study?  Is it presented in person or mailed (where they
can review it in the privacy of their own home)? How much time elapses between the
presentation of the study and informed consent form and the actual signing of the
form?  The answers to these questions will ensure the PI has considered this
component of the process and will reassure the IRB that the PI is allowing adequate
time for the participant to make an informed decision and minimize the possibility of
coercion or undue influence.  
Name
Description
Consent Process | History
 
 
Attach a plan for consenting
subjects. This must give detail
about the consent process. 
 
 17.11
Parental Permission and Youth Assent: Complete this question only if
enrolling minors. How will parental permission and youth assent (if
applicable) be obtained?  
Mothers of premature infants involved in the study will be approached and
informed consent will be obtained. If the mothers are minor, the guardian of the
mother will be approached for informed consent.
 
Give details of assent process
and assent form.
View: 17-02 Informed Consent Process II
 
17.2 Informed Consent Process II:
 
17.12 
What method will be used to document the consent process (i.e. a note in EPIC)? Not
how you will get consent only how you will document consent has been obtained, i.e
chart note, note in study file.  
A note in Epic EMR, note in study file
 
 
 i.e chart
note, note in
study file.
 
17.13
What type of Informed Consent will be used in this study? (check all that apply): 
Consent Type
Written/Signed Consent by Subject
Written/Signed Permission by Parent/Guardian
 
Check all that
apply
A non-return
cover memo
applies to a
study in
which you are
sending out a
questionnaire
with a memo
or letter that
informs
participants
about the
study but
does not need
to be signed
and returned.
If they
complete and
return the
questionnaire
they have
given
consent.
 
17.14
If other, please specify: 
 
 
If other,
please give
specifics. 

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****Attach all consent forms (Informed Consent, Genetic Consent and HIPAA) here:****
 
17.15
 Please attach a copy of each Informed Consent form(s) and HIPAA Authorization you are
using for this study: 
Name
Version
HMA ICF & HIPAA 6 17 tracked changes .docx
0.01
HMA ICF & HIPAA 6 18 clean.docx
0.02
 
 
Attach
Consent
form(s) and
HIPAA
Authorization
here
 
17.16
Will non-English speaking subjects be enrolled? 
Yes  
No        Clear
If the answer to 17.17 is no we will not be enrolling non-English speaking subjects then
tell the IRB why not? 
Study staff only knows English 
 
 
Check one
Please give
the IRB an
explanation
as to why
non-English
speaking
subjects will
not be
enrolled.
 
17.17
If non-English speaking subjects will be enrolled please provide information about the
person(s) obtaining consent (what language they will speak)and how you will deal with
written translation(s): 
 
Provide
information
about
translating
consents and
having
interpertative
services
available for
consent.
View: 18-00 Data Safety Monitoring I
 
Section 18.0 Data Safety Monitoring Plan
DATA AND SAFETY MONITORING PLAN GUIDE
 
WHEN DO YOU HAVE TO COMPLETE A DATA SAFETY MONITORING PLAN? 
 
FOR THE IRB- All intervenƟonal studies that are greater than minimal risk should have a Data Safety Monitoring Plan. The IRB reserves the
right to require a Data Safety Monitoring Plan for any study.
 
Archived IRB Data Plans - prior to 9/28/2010
 
 
 
FOR THE CRU-  ALL CRU PROTOCOLS [Recent NIH guidelines stipulate that all protocols that involve human
subjects, a signed consent form and are conducted on, or use the resources of, the CTSA Clinical
Research Unit - MHMC (CRU) are required to have a Data and Safety Monitoring Plan (DSM Plan).] 
 
What is a Data and Safety Monitoring Plan (DSM Plan)?
 
A DSM Plan is a prospectively defined strategy to assess the assumptions made in the trial design while the study is in progress.  Its main
purpose is to ensure the safety of participants in clinical research studies and the validity and integrity of research data collection. A properly
designed DSM Plan improves the scientific quality and yield from a clinical trial and the protection of human subjects.
 
The DSM Plan needs to address the nature of the safety monitoring and who will be conducting that monitoring.  It may be reasonable for a
single individual to perform the monitoring in a small trial with minimal/low risk while a local independent or an external data and safety
monitoring board (DSMB) may be required for more complex/high risk trials.
 
Key elements to be incorporated in a DSM Plan

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·          Assessment of risks and monitoring level
·          Safety contact: Who is responsible?  
·          Safety monitoring: Who will do it? How often?
·          Informed consent process; consistency with the protocol
·          Data collection process
·          Adverse Events Monitoring: Anticipated and unanticipated
·          Description of anticipated adverse events
·          Grading and attribution method
·          Reporting of unanticipated adverse events
·          Plans for periodic reporting
·          Impact on termination of subjects from the study and study closure
 
 
Step 1 - only for Investigators Using the CRU:
1.A Is your protocol approved  and supported by the Ireland Cancer Center?   
Yes 
No
If Yes - The Comprehensive Cancer Center Data and Safety Moniotoring Plan for Clinical Trials is on file.
Proceed to Step 5.1.B If No, Proceed and complete Steps 2-5
**********
Step 2 - all Investigators - Provide Information in order to determine the level of safety monitoring
required
2.A List all data collection types and study procedures (this information will pull from Section 8 Methods
and Procedures questions 8.1, 8.2, 8.3)
Data Collection types: 
Name
Chart Review - Prospective
Anthropomorphic evaluations
Social-Behavioral Procedures: 
Name
None of the Above Social-Behavioral Procedures Apply to this Study
Medical Procedures: 
Name
Study of Human Biological Materials (i.e. Urine Collection)
Study of Existing Data
Medical Tests, Comparisons, Evaluations
Special/prescribed diets
Anthropomorphic Measurments
**********
*You must select the risk level Please read the information below, check the applicable boxes and select
an appropriate risk level.
Level I: Minimal and Low Risk Studies (examples of studies that are minimal and low risk studies)
Types of Studies: 
Name
Anthropomorphic evaluations
Level II: Moderate Risk Studies (examples of studies with populations, drugs, and procedures that are moderate
risk)
Types of Studies: 
Name
Child Population
Level III: High Risk Studies (examples of diagnostic procedures and drugs or device studies which are high risk)
Types of Studies: 

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Name
There are no items to display
2.B If you do not see your study procedures on the above list please add in the procedures being done
for research purposes:
 Add additional risk(s): 
Procedure
DSMB Risk
There are no items to display
Select the Appropriate Level of Risk for this study based on the criteria above:
 Level of Risk: 
Risk Level I Mimimal and Low Risk Studies
     Now Select the appropriate Level of Monitoring and give your justification:
     2.C Rank Level of Monitoring (select one by checking the box)
     Minimal/Low/Moderate Levels of Monitoring 
     Justification for selecting Minimal/Low/Moderate Level of Monitoring Required: 
We are not introducing a new drug. We are only adjusting the amount of protein and fat given to premature infants based on the
analysis of their mother's breast milk composition in the intervention group. Outcomes measured are growth parameters and
anthropometric measurements when infants are clinically stable. The harm anticipated is no higher than those encountered in daily
life or during care in the NICU, therefore only needing low level monitoring.          
     High Level of Monitoring 
     Justification for selecting Risk High Level of Monitoring: 
    
       
    
    
    
    
    
  
     
    
  
    
    
    
 
   
    
   
 
   
 
 

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View: 18-01 Data Safety Monitoring II
 
18.01 Data Safety Monitoring II
 
 
A designee will perform the safety monitoring:  
  
Yes 
No
Identify the designee [provide contact information]: 
 
 
 
A medical monitor or independent individual/safety officer will be performing
the safety assessments. 
  
Yes 
No
Identify who will be performing the safety assessments [provide contact
information]:  
Dr. John Moore 
Professor of Pediatrics and Reproductive Biology  
Case Western Reserve University School of Medicine  
Director of the Division of Neonatology 
MetroHealth Medical Center  
2500 MetroHealth Drive  
Cleveland OH 44109 
Tel: 216-778-5946 
email: Jmoore@metrohealth.org
 
 
 
Has a Data Safety Monitoring Board or Committee been established for this
study? 
  
Yes 
No
Identify these members by name, title and qualifications. How often will the
DSMB meet? How frequently will the DSMB report it's findings?) data prior to
9/28/2010 read only. 
 
 
 
If there is a DSMB or DSMC is it a nationally constituted Data and Safety
Monitoring Committee?   
Yes 
No
Please enter the Name of Contact or Chair, Address and Phone or E-Mail: 
 
 
 
Is there a locally constituted Data and Safety Monitoring Committee or Board
that will perform the safety monitoring. Specify composition and
responsibilities in the box below. Note: Board Members should not have conflicts
with this study or with study personnel.   
Yes 
No
Names of Members of Local DSMB [provide contact information]: 
 
 
 
 
 
3.B.1 Description of anticipated adverse events. Pulled from question 10.5.
Targeted fortification- rare, some babies may have elevated BUN which is routinely
monitored in the NICU, or rare, feeding intolerance  
 
There is also risk of breach of confidentiality, but this is rare. Data will be stored
securely, only key study investigators will have access to data, and it will be
deidentified and only the PI will have access to the key.  
 
The probability and magnitude of harm or discomfort anticipated in the research are no
greater than those ordinarily encountered daily during routine care while admitted to
NICU.
 

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Additional Comments on anticipated adverse events: 
 
3.B.2 Safety data/procedure used to preform evaluation:
Data to be evaluated: 
Name
There are no items to display
Who will evaluate safety data: 
Frequency of Monitoring: 
Name
6 Months
 3.C. Grading method and attribution for adverse event reporting:  
Grading method and attribution for adverse event reporting
The PI must identify what scale will be used to grade adverse events
(AEs) and indicate his/her attribution/assessment of the relationship
between the adverse event and the protocol/intervention.  Each protocol
may have a unique approach to grading adverse events and the PI should
consult the parent protocol and/or funding source for specific grading
scales.  Suggested guidelines for the grading of adverse events are
available below:
 
Example A:        Cancer Therapy Evaluation Program (CTEP) Common Toxicity Criteria (CTC
II) available for viewing at http://ctep.info.nih.gov (see “Reporting
Guidelines, Common Toxicity Criteria”)
 
Example B:  Common grading scale
                                      0              No adverse event or within normal limits or not clinical
significant
                                      1              Mild AE, did not require treatment
                                      2              Moderate AE, resolved with treatment
3              Severe AE, resulted in inability to carry on normal activities
and required professional medical attention
                                      4              Life threatening or disabling AE
                                      5              Fatal AE
3.C.1 Identify the scale to be used to Grade AEs in this study:
CRU Safety Scale: 
Name
There are no items to display
3.C.2 Identify the attribution scale to be used in this study:
CRU Attribution Scale: 
Name
There are no items to display
3.D. Population being studied: (populated from your answers to Sections
11.00 and 12.00) 
Vulnerable subject groups? Yes
Children? Yes
Decisionally Impaired Subjects? No
Pregnant Women and/or Fetuses? No
Will you be enrolling Prisoners? No
Other Populations being studied:
 

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Vulnerable Populations
Vulnerable Populations
Poor / Uninsured
Minors - Children under 18
Employees
Students
Minorities
* Note More Frequent monitoring intervals may be needed for vulnerable
populations.
4.A. Plan for Adverse Event Reporting:
All Reportable Events (Anticipated and Unanticipated events) from this
protocol must be  submitted using the MHA eIRB Reportable event form in a
timely maner consistent with MHS IRB SOPs.
In addition to the MHS IRB adverse events and Uanticipated problems will be
reported to:
Reporting Institutions (check all that apply): 
Name
There are no items to display
If other has been selected above please specify: 
4.B Stopping Rules or Conditions under which Subjects can be removed from
the Study [this information is from Section 10.01 of the Protocol
Risks/Benefits Questions
Are there defined Stopping Rules?   Yes
What are the stopping rules for the study? Intolerance to fortification, excessive
emesis or recurrent, otherwise unexplained, abdominal distention.
What findings, events, or conditions would require a research subject to be
removed from the study? (i.e. disease progression) 
Clinical worsening, acute decompensation of infant precluding them from receiving
enteral feeds.  
If a patient become acutely ill and significantly decompensates they may be removed
from the study. Ex: sepsis, abdominal distention, blood in the stool, respiratory failure
with increasing need for respiratory support. If a patient becomes comfort-care only
and no longer receiving enteral feeds they may also be removed from the study.
4.D. Additional Information (if Applicable):
Provide any other information relevant to the data and safety monitoring plan
that was not already incorporated into this form.  
Attach A copy of your Data Safety Monitoring Plan or other relevant
information related to this form: 
Name
Version
There are no items to display
View: 19-00 Use of Human Biological Materials In Research I
 
19.0 Use of Human Biological Materials In Research I:
 
19.1 
Will Human Biological Materials be collected as part of this study? (i.e.
blood, tissue, fluids and substances etc.)  
Yes
If no, hit continue and you will be taken to the next page.
 
Check yes or no.
 
19.2
Will the storage or transportation of study materials place anyone at a
health risk? In other words, are these biohazardous materials? Will they
put the staff collecting them or transporting them at risk?  
No
 
Check yes or no. 
 
19.3 
If yes, please explain: 
 
Please explain the risks. Above

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and beyond universal
precautions.
 
19.4
Will information from the materials be stored in an electronic database? 
Yes
 
Check yes or no.
 
19.5
If yes, list the database(s) where the information from the materials will
be stored and who will have access to them: 
The data collected will be stored in the shared secure drive of MHMC secure
network and will be accessible only to the study team and will be password
protected. REDCap will also be used to store study data. REDCap (Research
Electronic Data Capture) is a secure, web application designed to support data
capture for research studies.
 
List the database(s) and who
will have access to them.
 
19.6
Human Biological Material Destruction: please describe the plan for
materials destruction (when, where, how and by whom): 
After study completion the breast milk will be disposed of by study personnel in the
lab in a sanitary waste drain. After rinsing, the sample vials will be disposed of in a
standard garbage dumpster.
 
Give the destruction plan i.e.
shipped back to sponsor for
destruction at end of study,
incinerated by Browning Ferris
3 months after study ends.
 
19.7
Storage of Human Biological Materials: please describe where, how and
for how long the materials will be stored: 
Once weekly the previous 24 hour breast milk sample that is provided by the
mothers will be mixed properly and a small aliquot will be collected. The samples
will be put into sample vials and stored in the refrigerator in the NICU along with
the remainder of the mother's breast milk supply. Each sample will then be taken
to the lab at Metrohealth with a unique ID and analyzed in the lab.
 
Physical storage of materials
where will it be, how will it be
stored and for how long.
 
 
View: 19-01 Use of Human Biological Materials in Research II
 
19.1 Use of Human Biological Materials In Research II:
    
 
19.8 
Does this research involve human cell/lines and/or products that are
made from human biological materials?   
Yes 
No
 If yes, please explain: 
 
Check Yes or No.
 
Please explain. 
 
19.9
Will Human Biological Materials (tissue, blood or salavia) be collected in
this study for genetic research? 
No
If Yes, please provide additional discussion of the genetic testing
components including who will conduct the tests: 
 
 
Check Yes or No. 
 
19.10 
If yes, can subject(s) decide not to participate in the genetic research and
still participate in the study? 
 
Check Yes or No. 
 
Please submit the appropriate genetic consent/tissue storage form and
attached at 17.15 
A template for this form can be found on the IRB Home Page. Note: if tissue
storage is mandatory for participation in a study the subject consent must be
included in the body of the consent form; if it is not mandatory it can be included
as a separate page at the end of the consent form.  
 
 
 
19.11 
Will NIH Genome-Wide Association Studies (GWAS) be conducted? 
  
Yes 
No
 
Check Yes or No.
 
19.12
Will you be sending samples/data to the NIH GWAS?   
Yes 
No 
 
Check Yes or No. 
 
19.13 
Will you be using sample/data obtained frm the NIH GWAS?   
Yes 
No
 
Check Yes or No. 

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19.14
Please provide justification for using NIH GWAS: 
 
Please explain. 
 
 
 
If this is a GWAS study you will need to submit a Patient Information Sheet
(add at 17.16). This sheet should summarize the Genetic research component
of this study and tell the subjects where their biological materials will be sent,
what analysis they will undergo, who will have control of them and for how long
and who to contact if they want to withdraw their permission. It must be clear to
subjects that these samples will not be housed at MHS nor will the MHS
Investigator retain control over them.
 
 
 
 
View: 20-00 Drug Information I
 
20.0 Drug Information I:
20.1 
* Does this study involve drugs? No
If you are doing a drug study you may be required by law to register that
study at Clinical Trials.gov Section 113 of the FDA Modernization Act
mandates registration with ClinicalTrials.gov of investigational new drug
efficacy trials for serious diseases or conditions.  For more information click
on the link below:
http://prsinfo.clinicaltrials.gov/registering.pdf
If you answer no and hit continue you will go to the next section. 
Does this study involve:  
Is the study drug(s) FDA approved for this indication?   
Yes 
No
Does this study involve use of a Placebo?   
Yes 
No
Does this study have a drug washout period?   
Yes 
No  
Do you have an IND?   
Yes 
No  
If yes please give the IND: (include a copy of the FDA approval letter at
20.4) 
Who is the sponsor or holder of the IND?  
Does this study have an IND exemption? (include a copy of the FDA
exemption letter at 20.4)   
Yes 
No  
 
If you check no and hit
continue you will go to the
next page.
 
20.2 
Fill in an entry for all drugs that will be used in the study:  
Drug Name
FDA Approved (yes, no)
IND Number
Supplied By
There are no items to display
 
Please give a complete list.
 
 
 
20.3 
Manufacturer (name, address):  
 
Answer only if produced
commercially.
 
20.4
Attach a copy of:
1.) Investigator Brochure and/or Package Insert
2. FDA Form 1571 Investigational new Drug Application Form
3.) FDA Form 1572 Statement of the Investigator Form
4.) FDA Correspondence (i.e. FDA Approval Letter for IND, FDA
Exemption letter)
 
Name
Description
There are no items to display
 
Attach the IB, 1572 and 1571
here.
 
View: 21-00 Medical Device Information I rev
 
21.0 Medical Device Information I:

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DeﬁniƟon of a Medical Device:
 An instrument, implement, machine, contrivance, implant, in vitro reagent, or other similar or related arƟcle,
including a component part, or accessory which is
•          Intended for use in the diagnosis of disease or other condiƟons, or in the cure, miƟgaƟon, treatment or
prevenƟon of disease in man or other animals.
•          Intended to aﬀect the structure or any funcƟon of the body of man or other animals, and which does not
achieve any of its primary intended purposes through chemical acƟon within or on the body of man or other
animals and which is not dependent upon being metabolized for the achievement of any of its primary intended
purposes.
In short any health care product that does not achieve its primary intended purposes by chemical acƟon or by being
metabolized. Medical devices include, among other things, surgical lasers, wheelchairs, sutures, pacemakers,
vascular graŌs, intraocular lenses, and orthopedic pins. Medical devices also include diagnosƟc aids such as
reagents and test kits for in vitro diagnosis (IVD) of disease and other medical condiƟons such as pregnancy.
 
21.1
Is this a Medical Device Study? Yes
If you are doing a device study you may be required by law to register
that study at Clinical Trials.gov Section 113 of the FDA Modernization Act
mandates registration with ClinicalTrials.gov of investigational new device
efficacy trials for serious diseases or conditions.  For more information
click on the link below:
 
http://prsinfo.clinicaltrials.gov/registering.pdf
If you answer no and hit continue you will go to the next section. 
 
Answer yes or no.
 
21.2 
Medical Device Generic Name: 
Breast milk macronutrients test system
 
Give generic name. 
 
21.3
 
21.4
Medical Device Brand Name:  
Miris Human Milk Analyzer
Medicare Code Number: 
 
 
As stated in regulations 21 CFR 812.3(m), a device may be considered a,
Significant Risk Device, if it meets any of the following criteria and a
determination is made by the IRB that the device presents a potential for
serious risk to the health, safety or welfare of a subject.
 
Give brand name. 
 
21.5 
Is this device intended as an implant? No
 
Check one
 
21.6
Is device to be used in supporting or sustaining human life? No
 
Check one
 
21.7
Is the device for use of substantial importance in diagnosing, curing,
mitigating, or treating disease or otherwise preventing impairment of
human health?  
No
 
Check one
 
21.8
Does this device present a potential for serious risk to the health, safety,
or welfare of a subject?  
No
 
Check one
 
21.9
If you answered NO to all the above, or if an initial risk assessment has
determined that this is a non-significant risk device (21CFR 812.3), attach
the appropriate documentation for this justification:  
Name
Description
MIRIS FDA.pdf | History
 
 
Attach justification. 

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21.10
What is the regulatory status of the study device?  
FDA Class II Device
 
Provide information on the
regulatory status of the device.
 
21.11
What is the long term plan for device management once the study closes? 
Once the study closes the device will remain in the lab at MetroHealth for future
clinical and research use.
 
Provide information such as
how you will communicate
important information to
subject; plan for
maintenance/repairs; contact
information besides the PI.
View: 21-01 Medical Device Information II
 
21.1 Medical Device Information II:
 
21.12 
What is the FDA Approval date? 
12/21/2018  
 
Please give date. 
 
21.13
What is the Premarket Approval (PMA)number?  
 
Please give number.
 
21.14 
What is the Premarket Notification (510K) number?  
 
 
Please give number.
 
21.15
What is the Investigational Device Exemption (IDE) number?  
Who is the sponsor or holder of the IDE?  
 
 
Please give IDE number if
applicable.
 
21.16
What is the Humanitarian Device Exemption (HDE) number?  
 
 
Please give HDE number if
applicable.
 
21.17
Has this medical device ever been used in animals? 
No   
 
Check one
 
21.18
If yes, please give a brief summary of the results of studies involving
animals: 
 
 
Give a brief summary or
attach one below at 22.16.
 
21.19
Please attach supporting documents: 
Name
Description
Miris Manual | History
 
 
Give a brief summary.
View: 21-02 Medical Device Information III
 
 
21.2 Medical Device Information III:
 
21.20 
 Has this medical device ever been used in humans? Yes  
 
Check yes or no.
 
21.21
If yes, please give a brief summary of the results from studies involving
humans:  
This device has been used extensively in Sweden in the NICU to analyze
mother's breast milk. This information is used to individualize fortification
to meet each infant's nutritional needs.
 
Give a brief summary.
 
21.22 
Please list all research personnel authorized to use the study device: 
Name
Employer
Department
Employer Name
Sharon Groh-Wargo MHS
Pediatrics
The MetroHealth System
Stephanie Merlino
MetroHealth Neonatal
The MetroHealth System
Stacey Ramey
MetroHealth Pediatrics, Neonatology The MetroHealth System
 
List all research personnel
authorized to use study
device.
 
21.23 
How will this medical device be used in research? 
We will perform weekly analysis of breast milk, for the infants in the targeted
fortification group will have the milk fortified to meet their nutritional needs.  
 
The intended use of the Miris human milk analyzer: to quantitatively measure the
concentration of fat, protein, carbohydrate, total solids, and energy in human milk.
These measurements will be used to aid in the nutritional management of the
infants included in this study.
 
Give a brief description.
 
21.24
Please list all possible complications:  
Inaccurate measurement of macronutrients of breast milk is a risk, and
inappropriate fortification may be a complication. This will be minimized by
 
List all complications.

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following the device manual instructions, testing control samples provided by the
manufacturer to evaluate for accuracy as instructed by the manufacturer, and
carefully calculating and adjusting each neonates nutritional needs based on the
result.
 
21.25
Please list all precautions, warnings, and contraindications:  
The device will only be used for analysis of human milk. If the mother has
inadequate supply to provide a sample for analysis then the human milk analysis
will not occur. The device will be used as instructed by the user manual and all
safety monitoring protocol will be followed.
 
List all precautions, warnings
and contraindications.
View: 21-03 Medical Device IV
 
21.03 Medical Device IV     
INVESTIGATOR’S RESPONSIBILITY FOR CONTROL OF THE INVESTIGATIONAL DEVICES:
To protect the rights, safety and welfare of research participants the investigator must ensure control and
accountability of all devices used in conjunction with clinical research protocols. To make certain that
investigational devices are used only on research participant’s who have signed the informed consent form specific
for the device and IDE number. 
 
21.26 
  The device will not be used on a research participant until FDA(when FDA
regulated investigational device is being studied) and IRB approval has been
obtained and the research participant has signed an informed consent document.
 
Please check these boxes
 
21.27
  The informed consent document will inform the research participants that
their names and information will be shared with the device company for tracking
purposes.
 
 
 
21.28 
  The investigation will be conducted in accordance with the signed agreement
with the sponsor, the investigational plan, and all applicable laws and regulations.
 
 
 
21.29
  The device will be used only in accordance with the MHS IRB approved
protocol.
 
 
21.30
  The Investigator is thoroughly familiar with the appropriate use of the
investigational device, as described in the protocol, in the product information, and
in other information sources provided by the sponsor.
 
 
21.31
  All persons assisting with the trial are adequately informed about the protocol
and the investigational product(s).
 
 
21.32
  Devices will be properly maintained and cleaned.
 
 
 
21.33
  Research participants will receive adequate instructions about the
investigational device to assure their safe participation in a research study.
 
 
 
 
 
 
 
21.34
Any investigational devices used in conjunction with an investigational protocol must be kept in a
locked and secured area. Access to investigational devices must be limited to personnel designated by
the Principal Investigator. Please describe How you will secure the investigational devices to be used
in this study and who will have access to them. 
The analyzer will be kept in the lab at MetroHealth. Only the study personnel will have access to the key to the
lab.
 
 
21.35 
Attach copies of device logs, see examples of logs on the IRB Home Page in the IRB Guidelines Section
under MHS Medical Device Guidelines : 
Name
Version
There are no items to display
 
 
 
 
 
 
 
 
View: 22-00 Clinical Trials Registration

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22.0   Clinical Trials Registration:
Note: Phase 2 - 4 trials of drugs and biologics (controlled clinical investigations other than Phase 1 investigations of a product
subject to FDA regulation) AND trials of devices (controlled trials with health outcomes, other than small feasibility
studies and pediatric post-marketing surveillance) must be registered per the Food and Drug Administration Act of
2007;  NIH encourages registration of all trials, regardless of whether required under applicable law.
How are study protocols submitted to ClinicalTrials.gov? 
The FDA Guidance Document (March 2002) (http://www.fda.gov/cder/guidance/4856fnl.htm) describes the submission criteria.
The NLM has developed the Protocol Registration System (PRS), a Web-based tool for submitting information to
ClinicalTrials.gov. Study sponsors or their representatives may register online to apply for a PRS account
(http://prsinfo.clinicaltrials.gov/).
 
22.1 
Has this trial been registered on www.clinicaltrials.gov? 
  
Yes 
No
 
Web link to clinical trails
website. 
 
22.2
If Yes, who registered the trial?(i.e. sponsor, investigator) 
 
 
Please respond 
 
22.3 
Please provide ClinicalTrials.gov Identifier (i.e. NCT00391872)
 
 
The sponsor can provide you
with this information or you
can look it up on the website.
 
 
 
22.4
If No, are there plans to register the study?   
Yes 
No
 
If you answer No you must
provide an reason why this
study will not be registered.
 
22.5
If the answer to 22.4 is No, provide and explanation: 
This is a research study that is using a medical device with FDA approval.
 
Provide a response if the
answer to 22.4 is No.
 
 
 
 
 
 
View: 23-00 Interview/Focus Groups
 
23.0 Interview/Focus Groups:
 
23.1 
Does this study involve Interviews/Focus Groups? No
If you answer no and hit continue you will go to the next page.
 
Answer yes or no.
 
23.2
 
Attach copies of any scripts/or questions that will be used to guide the
interview focus/groups: 
Name
Version
There are no items to display
Attach scripts or questions.
 
23.3
Idendtify all Staff conducting interviews on page 1 question 1.4 by
selecting the correct role.
 
 
23.4 
Is there any specific training or qualifications needed to conduct the
interviews/focus groups? 
 
Describe training and/or
qualifications. 
View: 24-00 Psychological Testing
 
24.0 Psychological Testing:
 
24.1 
Does this study involve Psychological testing? No   
If you answer no and hit continue you will go to the next page.  
 
Answer yes or no.
 
24.2 
First Please list all Psychological Tests that will be given: 
 
First please list the
test(s)/measures to be used. 

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24.3
Attach copies of all psychological test(s)/measures that will be used for
this study: 
Name
Version
There are no items to display
 
Second attach copies of all
test(s)/measures.
 
 
 
 
24.4
Is there any necessary training or licenses required of those
administering the psychological testing? 
Idendtify all Staff Administering tests on page 1 question 1.4 by selecting
the correct role.
 
Describe any training or
licenses required to administer
test(s).
View: 25-00 Surveys/Questionnaires
 
25.0 Surveys/Questionnaires:
 
25.1 
Does this study involve Surveys/Questionnaires? No
If you answer no and hit continue you will go to the next section.  
 
Answer yes or no.
 
25.2
Please attach all questionnaires and/or surveys to be used in this study: 
Name
Version
There are no items to display
 
Attach
survey(s)/questionnaire(s).
 
25.3
Idendtify all Staff conducting Surveys on page 1 question 1.4 by selecting
the correct role.
 
View: 26-00 Deception
 
26.0  Deception:
Deception is a research methodology. When deception is used in research the subject is not told, or is
misled, about the true purpose of the research, such as in certain studies of group processes, contextual
influences on cognition, etc.
 
 26.1 
Does this study involve the use of deception as a study design method for
the research? 
No  
If you checked no then hit the continue button and you will be taken to the next
page.
 
Deception is defined as
intentionally misleading or
withholding information about
the nature of the experiment. 
 
26.2
Describe in detail the nature of the deception and explain why this is
necessary for the research: 
 
Please describe the nature of
the deception. 
 
26.3 
State how, when and by whom the research subjects will be debriefed: 
 
Briefly describe your plan to
debrief subjects. 
View: 27-00 Additional Documents
 
27.0 Additional Documents:
 
27.1 
Are there any additional study documents you wish to attach to this
application?   
Name
Version
There are no items to display
 
Attach any additional study
documents i.e protocols supplied
by sponsor.
View: The End
 
To Finalize this application you must do two things:
1.) As a final step you should click on Hide/Show Errors on the top of this page. If there are any required fields in the Application
you have omitted they will show up in red. If you click on each item you will be taken to that page of the application so you can

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complete the question.
Note: Unless all named Co-investigators have agreed to participate you will not be able to submit your study. Co-Investigators have
to press the Co-Investigators agree to participate button. You can send them an email message tellng them to do this by pressing
Notify Co-Investigators of Need to Agree to Participate. The minute you have selected your Co-Investigators you can press this
button it is not advisable to wait until you have completed the application as it may hold up your submission.
When all error messages are gone then... 
2.) Click Finish
Please click on the "Finish" button to finalize and exit the Study application.  Doing so will NOT submit the application for review.  
3.) The PI must press the Submit Study button (when they are ready to submit to the IRB)
Please note that a submission may only be forwarded to the IRB by the Principal Investigator.  To do this, the Principal Investigator
must push " Submit Study" in the blue area on the left hand side of the page under My Activities. Only the PI will have this
button it will not be visible to any other study team members. 
You can track the ongoing status of your submission by logging into the study workspace. On the top left hand side of the page in
the light blue area there will be a box labeled with the Current State of your study. 
Please contact the IRB with any questions or concerns. When calling the IRB Office Please direct your questions to the IRB staff
named as the "Owner" of your study. 
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Stacey Ramey 
Study Role: 
Name
Responsible Investigator (Resident PI one RI required)
DRA (only one)
Obtaining Informed Consent
eIRB Notification Recipient
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Stephanie Merlino 
Study Role: 
Name
Co-investigator
Obtaining Informed Consent
View: CCF Key Personnel Questions View
* Name of Key Personnel Working on Study:  Mathavan Sivarajah 
Study Role: 
Name
Obtaining Informed Consent
View: CRU DSMP Data Collection Simple View
Name: Anthropomorphic evaluations 
Level of Risk: Minimal and Low Risk Studies 
Type: Data Collection
View: CRU DSMP Data Collection Simple View
Name: Child Population 
Level of Risk: Moderate Risk Studies 
Type: Study Population