Clinical Assessment of the Missouri Osteochondral Allograft Preservation System: Lifelong Registry
Conditions: Symptomatic Osteochondral Defect(s), Cartilage, Meniscus, Ankle, Knee, Shoulder, Hip
Sponsor: University of Missouri-Columbia

Official Title of the Study 
Clinical Registry Assessment of the Missouri Osteochondral Allograft 
Preservation System - MOPS 
 
NCT Number 
NCT02503228 
 
Date of the Document:  
07/14/2015 

IRB #2003053 HS
Repository/Database Application #206420
Submission date: 07/14/2015 
Submitted by: Rucinski, Kylee Jenae 
1. Investigators
Project title (do not use all capitals)
Provide the full title of the project.
Missouri Orthopaedic Institute Regenerative Orthopaedics and Joint Preservation Registry 
Study Staff (students, fellows & residents must have a faculty member as a co-investigator)
1. 
2. 
MU eCompliance
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Page 1 of 18

Role
Investigator
Department
CITI IRB
Training
Consent
personnel role
Primary
contact
Truman VA
Hospital
personnel
Principal
Investigator
Cook, James L
Orthopaedic
Surgery
10/28/2019
Authorized to
Obtain Consent


Co-
Investigator
Stannard, James
Patrick
Orthopaedic
Surgery
05/03/2020
Authorized to
Obtain Consent


Research
Coordinator
Cunningham,
Suzin Marie
Orthopaedic
Surgery
01/22/2019
Authorized to
Obtain Consent


Research
Coordinator
Durante, Elizabeth
Cole
Orthopaedic
Surgery
02/26/2020
Authorized to
Obtain Consent


Research
Coordinator
Rizzo Esposito,
Ennio Antonio
Resident
Orthopedics
04/18/2019
Authorized to
Obtain Consent


Research
Coordinator
Suzzarini, Maria
Luisa
Orthopaedic
Surgery
07/12/2019
Authorized to
Obtain Consent


Research Staff
Blecha, Kyle M
ATC Program
11/26/2019
Authorized to
Obtain Consent


Research Staff
Clawson, Stacee
Wise
Orthopaedic
Surgery
04/30/2019
Authorized to
Obtain Consent


Research Staff
Clemons, Bryce
Asher
Orthopaedic
Surgery
11/30/2019
Participate in the
Process


Research Staff
Friedman, Steven
C
Orthopaedic
Surgery
04/12/2020
Non-Consenting
Personnel


Research Staff
Humpherys,
Joseph
Resident
Orthopedics
08/03/2018
Authorized to
Obtain Consent


Research Staff
Jones, Vicki Lynn
Orthopaedic
Surgery
05/23/2019
Authorized to
Obtain Consent


Research Staff
Leary, Emily
Vanessa
Orthopaedic
Surgery
05/28/2020
Non-Consenting
Personnel


Research Staff
Livesay, Lauren
Nicole
Orthopaedic
Surgery
05/01/2018
Authorized to
Obtain Consent


Research Staff
Love, Jessica
Windsor
Orthopaedic
Surgery
03/10/2020
Non-Consenting
Personnel


Research Staff
Mozingo, Nathan
Orthopaedic
Surgery
03/21/2020
Authorized to
Obtain Consent


Research Staff
Oladeji,
Lasunkanmi O
Resident
Orthopedics
03/16/2019
Authorized to
Obtain Consent


Research Staff
Pashuck, Troy
Daniel
Resident
Orthopedics
04/27/2018
Authorized to
Obtain Consent


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Role
Investigator
Department
CITI IRB
Training
Consent
personnel role
Primary
contact
Truman VA
Hospital
personnel
Research Staff
Rucinski, Kylee
Jenae
MOI Joint
Preservation
Center
05/02/2018
Authorized to
Obtain Consent


Research Staff
Schreiner, Anna
Janine
Orthopaedic
Surgery
11/02/2019
Authorized to
Obtain Consent


Research Staff
Si, Zhengye
Orthopaedic
Surgery
09/07/2018
Non-Consenting
Personnel


Research Staff
White, Branden
Perry
Orthopaedic
Surgery
06/17/2019
Non-Consenting
Personnel


Research Staff
Williams,
Jonathan Chase
Orthopaedic
Surgery
04/02/2019
Non-Consenting
Personnel


Research Staff
Wilson, Nichole
Suzanne
Orthopaedic
Surgery
01/07/2020
Authorized to
Obtain Consent


Research Staff
Wissman, Robert
David
Radiology
10/11/2019
Non-Consenting
Personnel


Research Staff
Worley, John
Robert
Resident
Orthopedics
05/04/2020
Authorized to
Obtain Consent


Research Staff
Zelasko, Eric R
Orthopaedic
Surgery
06/13/2019
Non-Consenting
Personnel


Research Staff
Zitsch, Bradford
Paul
Dean - Medical
Education
06/07/2019
Non-Consenting
Personnel


Contact Information
Principal investigator
Cook, James L
Job title
PROFESSOR
Department
Orthopaedic Surgery
Division
Medicine
Business unit
University of MO-Columbia
Primary contact
Clawson, Stacee Wise
Job title
DIR I RESEARCH OPS AND PLNG
Department
Orthopaedic Surgery
Division
Medicine
Business unit
University of MO-Columbia
3. 
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Rucinski, Kylee Jenae
Job title
SPVSR, REV MGMT
Department
MOI Joint Preservation Center
Division
Mo Orthopaedic Institue
Business unit
Hospital
Conflicts of Interest
Describe any Conflicts of Interest with this study.
Example: Financial, Personal, Institutional, or Other, for any study team member. If none please indicate
N/A.
N/A
Do all study team members have a current, up-to-date MU Conflict of Interest Disclosure on file
with the Office of Research?
for more information click the link to the COI website http://research.missouri.edu/complia/
coi_new2.htm
 Yes    No 
Has it been updated to include the conflict with this study?
 Yes    No    N/A   
Will the team include external investigators not affiliated with the University of Missouri-Columbia?
 Yes    No 
If yes, identify the investigator(s) and their institution and describe their role in the study.
Specify if the external investigator(s) will interact or intervene with the participants in the study or have
access to their private identifiable information. Also, clarify whether they will obtain informed consent from
participants.
4. 
A. 
B. 
C. 
5. 
6. 
2. Funding Information
How is this project funded? *
No Cost
Internal Funding
External Funding
1. 
 None (There is no cost associated with this project.)
 Internal Grant (ex. Research council, etc)
 Personal funds
 Departmental Funding
 HHS funded (The Department of Health and Human Services)
 Industry Sponsor (ex. Pharmaceutical company, device company, etc) * IRB fees apply
 External Grant (ex. Federal funding, foundation funding)
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Sponsor or Funding Source Information
If this study is sponsored please provide the MU Sponsored Program Grant Proposal Number (OSPA)
If you receive funding after IRB approval, please update this information using the Identification Form.
 In-kind (donation of equipment or services)
2. 
3. 
3. Protocol Information
Protocol Information
All applications must submit a protocol in addition to the grant application with the application materials. 
The information provided below will be reflected in your approval letter.
Protocol Number
Please upload a copy of the protocol under document storage. This link is located at the end of the
application on the page for submission.
Protocol Version Number
Protocol Version Date
Informed Consent
The information provided below will be reflected in your approval letter.
Informed Consent Version Number
Leave blank unless you have a sponsor provided version number in the footer of your consent.
Informed Consent Version Date
Leave blank unless you have a sponsor provided version date in the footer of your consent.
1. 
A. 
B. 
C. 
2. 
A. 
B. 
4. Location of Research
Is this a multi-center study?
A multi-site study is defined as a research study being conducted at multiple sites. Studies being conducted
at more than one MU facility are not considered multi-site.
 Yes    No 
If this is a multi-center study, is MU functioning as the lead site?
 Yes    No    N/A   
Does another institution(s)/organization(s) IRB want to Rely on MU IRB Approval?
If yes, a subform will automatically generate for your completion at the end of the application.
1. 
2. 
3. 
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 Yes    No 



5. Project Information
List all committees (other than the MU HS IRB) that have and/or will review this project.
VA Research and Development 
Institutional Biosafety 
Other 
If other, please list:
What is the purpose of creating this repository (or database)?
This project will be used to capture data from previous and future patients of the Regenerative Orthopaedics
and Joint Preservation Center in order to catalog them into a database. This data will be collected and
analyzed in order to provide outcome measures and ongoing tracking of the Joint Preservation Center's
patient population. Analyzing this data will allow staff to identify trends in patient populations over time.
Describe the subject's participation:
What will be expected of the participants?
The registry will be a database that contains information about past and present patients of the Center for
Regenerative Orthopaedics and Joint Preservation at the Missouri Orthopaedic Institute. The potential
subjects will be asked to give their consent to be a part of the registry, and the retrospective patients will be
asked to give consent to provide further information if further data capture is needed from them. 
1. Name 
2. MRN 
3. DOB 
4. Gender 
5. Age 
6. Race 
7. Height 
8. Weight 
9. BMI 
10. Preop activity level 
10. Insurance Carrier 
11. Dx 
12. Mechanism of Injury 
13. Preop imaging – XR, CT, MRI, scope 
14. Tobacco Use 
15. Diabetes 
16. City/State/Country 
17. Affected Joint 
18. Injury type (i.e. meniscus, ACL, etc.) 
19. Surgical Procedure Performed 
20. Non-Operative Procedures Performed and Date (PRP, etc) 
21. Contact Phone Number 
22. Secondary Phone Number 
23. Email 
24. Surgical Side 
25. Location of treatment 
1. 
A. 
2. 
3. 
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26. DOS 
27. Surgeon 
28. Patient reported outcomes 
Provide a project summary for non-medical and community members on the IRB.
The IRB includes members without a scientific or medical background. Using lay language, provide a brief,
but thorough, summary of the project.
The Center for Regenerative Orthopaedics is seeking to create a registry that will track patient data in order
to identify trends among patient populations. It is the hope of the CRO that this database will allow doctors
to provide better outcomes for patients by identifying techniques and procedures that have positives
outcomes for similar patients. This institutional registry will allow surgeons to assess the outcomes of
regenerative orthopaedic patients, to evaluate the effectiveness of quality improvement initiatives on short
and long term outcomes, and to engage new technologies while providing timely identification of success
and failures.
Procedures/Tests/Surveys
Please Note: List all tests and surveys that will be performed during the study. These tests should include
tests done for medical purposes ONLY IF the data will be collected for the research.
Procedures/Tests/Survey #1
PROMIS v.1.1 - Global
Name of test/procedure
PROMIS v.1.1 - Global
Brief description
Standard of care survey given to patients at follow-ups to check their overall health.
Relationship
Indicate the study visit(s) at which this will occur
Initial visit and every follow-up after.
Where will this test take place?
In person via OBERD, or emailed through OBERD.
Procedures/Tests/Survey #2
Tegner Activity Level Scale
Name of test/procedure
Tegner Activity Level Scale
Brief description
Measures the change of abilities in surgery patients before and after surgery.
Relationship
Indicate the study visit(s) at which this will occur
Each follow-up.
4. 
5. 
1. 
2. 
3. 
 Routine care where the information/data will be collected for the research study
 Research Only
4. 
5. 
1. 
2. 
3. 
 Routine care where the information/data will be collected for the research study
 Research Only
4. 
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Where will this test take place?
Either in person using OBERD, or by email using OBERD.
Procedures/Tests/Survey #3
IKDC Form
Name of test/procedure
IKDC Form
Brief description
International Knee form that documents the ability of the patient.
Relationship
Indicate the study visit(s) at which this will occur
Pre-op and follow-ups.
Where will this test take place?
Electronically through OBERD or via OBERD through email.
Subject Participation
How long is the subject actively participating in the research?
Throughout the treatment of their injury.
Visit Information
Number of total visits:
all standard of care visits
Frequency of visits:
standard of care 
Length of visits:
N/A
Inclusion criteria: 
Alll patient of the center will be considered for inclusion. Patients must have the ability to understand the
consent form and to provide consent for participation in the registry.
Exclusion criteria:
1) Patients who are unable to provide informed consent due to inability to understand written or spoken
English language or secondary consent through an interpreter 
Review requested
Expedited
5. 
1. 
2. 
3. 
 Routine care where the information/data will be collected for the research study
 Research Only
4. 
5. 
6. 
A. 
7. 
A. 
B. 
C. 
8. 
9. 
10. 
6. Subject Recruitment
Explain how you will have access to a population that will allow recruitment of the required number of
subjects in the proposed recruitment time. 
1. 
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




(For example, will you be going to a particular location, are they potential patients in the clinic, etc.)
Any patient of the Regenerative Orthopaedics and Joint Preservation Center makes up this population. They
will be patients that organically decide to come to the Center, as well as patients referred there.
Retrospective patients will be called by the number they provided at time of their initial consultation, or will
be approached at a follow-up visit to collect additional outcome data if needed.
Target accrual
For all MU sites, how many people do you expect to complete the study?
You may indicate undetermined or unknown.
The goal is to enroll any willing subjects with no max on possible completions of the study.
How many people will be enrolled (sign the consent) to reach the number listed in the previous
question?
For some studies this number may be the same, for other studies there may be a high rate of screen
failures.
Any patient that meets the criteria and decides to participate will be enrolled, with no max on
enrollments.
If this is a multi-center trial, what is the study wide target accrual?
N/A
What methods will be used to identify and recruit subjects? 
Check all that apply. Please note, if you are recruiting with a flyer, you may need a waiver of documentation
of consent if you are screening subjects before they sign a consent.
Flyers 
Advertisements 
Letters 
Patients of the PI/Co-I 
other 
If other, please explain.
What methods will be used to avoid inadvertent coercion in the recruitment process?
Patients will be advised that participation in the registry is not required as part of their medical treatment,
and that they may refuse to participate without any change to their treatment.
2. 
A. 
B. 
C. 
3. 
A. 
4. 
7. Consent Process
Repository Banking Consent Template
This section should only be completed for studies using Written Consent or Waiver of Documentation
(Signature). Please click the link above to access the CONSENT TEMPLATE.
Describe the consent process.
1. 
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Describe in detail how the consent process will be presented to the subject, how subject comprehension of
the study is determined, where and when consent is performed, and how questions from the subject are
answered.
Prospectively: All patients of the Center for Regenerative Orthopaedics and Joint Preservation, who meet
entry criteria, will be offered the opportunity to participate. They will be advised that participation is
voluntary. They will either be given a hard copy of the consent/HIPAA document to read and sign, or they will
read an electronic version of the consent/HIPAA document on an iPad, and give their consent by clicking a
button on an iPad in OBERD. This is a button that states they consent to the research study (please see
uploaded example) but is not a signature. Research staff will be aware that a patient chose to participate in
the study by routinely looking at OBERD generated reports that states which patients have chosen to enroll.
Retrospectively: data will be collected on patients who meet our study criteria. We will be asking for
permission to waive the HIPAA authorization and consent for the retrospective subjects for all previously
collected data. We will also be reaching out to retrospective patients via phone if further data collection is
necessary. The retrospective subjects who are contacted by phone will be asked to consent via waiver of
documentation of consent/phone screening script and we may utilize OBERD for retrospective patients if
they desire to fill out the surveys by email. 
How long will participants be given between the time they are approached to participate and signing
the consent for participation.
The regulations require investigators to seek consent only under circumstances that provide the prospective
subject or the representative sufficient opportunity to consider whether or not to participate minimizing the
possibility of coercion or undue influence.
Patients will be given as long as possible to consider before being asked to consent. If the patients are
comfortable with the Registry and are willing to consent at the time of their first clinic appointment, this
would be acceptable.
Patients will be allowed to provide consent either before their surgery date or after they return for
postoperative follow-up.
Please indicate how the language level of the consent matched to the comprehension level of your
prospective participants?
Note: The regulations require the information be understandable to the subject or the representative so
please consider the subject population and type of study.
The consent form will be written to be comprehended by an 8th grade reading level and will be confirmed
through appropriate personnel.
What measures will be taken to ensure the prospective participant/representative understands the
consent?
Patients will be given time and will be allowed to ask questions before consideration of consent.
Informed Consent
Who will be approached for informed consent?
Mark all that apply:
If other, please explain.
2. 
3. 
4. 
5. 
A. 
 Subject
 Subject`s parent or legal guardian
 Other
B. 
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Subject Privacy
Note: Privacy refers to a person, not the confidentiality of their data.
If subjects have an expectation of privacy, please describe your plan to protect their privacy during
and after the course of the data collection?
Data Security Data will be maintained in a file on a secured computer with password protection.
Data maintained in the MU/MOI institutional repository will be kept on secured servers. If the data is
transferred to external agencies with associated PHI, appropriate encryption processes will be utilized
to ensure that the data is not subject to discovery in the process of transmission.
No highly sensitive patient information (e.g. Hepatitis, HIV, other communicable disease states) will be
included in the registry data obtained from patients. Information regarding causative organisms (e.g.
MRSA, Staph, Strep, etc) may be included in the data set, but will not be transmitted outside the data set
(infection status only will be identified externally).
What are the consequences to subjects if a loss of privacy were to occur (e.g. risks to reputation,
insurability, embarrassment, other social risks)?
Consequences from a loss of privacy will be minimized by the types of data that will be obtained.
The expected likelihood of inadvertent disclosure of data is expected to be minimal. 
Describe the methods for identifying data/samples for which consent has been withdrawn or will
ensure no future use.
Indicate if there is a point where withdrawal would not be possible.
Patients may elect to withdraw from the registry on written request. 
6. 
A. 
B. 
7. 











8. Confidentiality and Security
Confidentiality
Confidentiality concerns data, specifically the researchers plan to handle, manage, and disseminate the
participant’s identifiable private information.
PLEASE INDICATE ALL IDENTIFIERS THAT MAY BE INCLUDED IN THE RESEARCH RECORDS FOR THE STUDY. 
CHECK ALL THAT APPLY.
Names 
Dates 
Postal Address 
Phone Numbers 
Fax Numbers 
Email Addresses 
Social Security Number 
Medical Record Numbers 
Health Plan Numbers 
Account Numbers 
License or Certificate Numbers 
1. 
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



















Vehicle ID Numbers 
Device Identifiers or Serial Numbers 
Web URLs 
IP Address Numbers 
Biometric Identifiers 
Facial Photos or Images 
Any Other Unique Identifier 
None of the 18 Identifiers Listed Above 
Data Security
Will any web applications be utilized for such purposes as recruiting subjects or processing data?
 Yes    No 
Will you be utilizing REDCap (Research Electronic Data Capture)?
 Yes    No 
List all web applications that will be used.
OBERD utilizes web-based technology to allow patients to access the PROMs remotely.
Patient information (e-mail, phone/text) will be provided at their discretion, if they wish to use
electronic means for communication/notification of survey availability. 
Describe the security features for the web application(s).
Standard, CFR Title 21 Part 11 complaint encryption. 
Will the data be collected and stored as:
Hard Copy 
Electronic (Hard Drive - best practice is to encrypt the PC) 
Electronic Portable (mobile) device (For VA the device must be encrypted and is FIPS-140-2 validated)
Hard Copy and Electronic 
Check the appropriate box below:
Data are coded; data key is destroyed at the end of the study 
Data are coded; data key is kept separately and securely 
Data are kept in locked file cabinet 
Electronic data are protected with a password 
Electronic data are encrypted 
Data are kept in locked office or suite 
Data are stored on a secure MU network 
Data are stored on a secure VA network 
If data are coded and the data key will be destroyed, please provide the anticipated date of
destruction:
If you plan to disclose any of the identifiers listed above as part of the study process, check all that
apply:
2. 
A. 
B. 
C. 
D. 
3. 
4. 
A. 
5. 
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






No identifying information will be disclosed. 
The subject's medical record 
The study sponsor 
Foreign Country or Countries 
The US Food & Drug Administration (FDA) 
Other 
If other, please specify.
How will the data be stored while the repository (or database) is active?
Data will be stored on a secured server. The partnering database (OBERD) obtains data through the MU
electronic portal. Registry data that combines OBERD data with Hospital coding data, and OR obtained
patient implant and operative details will be electronically entered into the registry. If the registry is
maintained exclusively within the University, this will be utilizing REDCAP. If the MU-MOI export data into
OBERD, the registry may be maintained with OBERD.
How will the data be stored/discarded after the study is completed?
The data will be maintained indefinitely
Check this box to confirm you will retain all research records for a period of seven years following the
completion of the study, in accordance with MU Policy. 
Certificates of Confidentiality
For more information on Certificates of Confidentiality, please go to http://grants.nih.gov/grants/policy/coc/
Will this research collect any information that may require a Certificate of Confidentiality?
Certificates of Confidentiality are issued to protect identifiable research information from forced
disclosure. They allow the investigator and others who have access to research records to refuse to
disclose identifying information on research participants in any civil, criminal, administrative, legislative,
or other proceeding, whether at the federal, state, or local level.
 Yes    No 
If YES, has a Certificate of Confidentiality been applied for?
 Yes    No 
A. 
6. 
7. 
8. 
A. 
B. 



9. Risks and Benefits
Pregnancy
Please indicate if any specimen collection may affect (known/unknown) an unborn child.
N/A
B. If applicable, how will pregnancy be determined:
Verbal confirmation 
Serum 
Urine 
1. 
A. 
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If participants with reproductive potential are involved, what contraceptive measures will be taken for
both females and males during the active phase of the study?
N/A
Indicate risks associated with specimen (or other data) collection.
For example, bruising due to blood draw.
N/A
What procedures will be used to prevent and/or minimize any potential risks and discomfort?
N/A
What are the potential direct benefits to the subject?
If there are no direct benefits, state none.
The subject may not personally benefit from having their information entered into the database, but they
will be contributing to medical knowledge. 
What are the potential benefits to the community and/or society?
The subject will be contributing to medical knowledge, specifically the knowledge related to joint health and
regenerative orthopaedics. 
Are there any other options for participants?
Patient can choose not to participate in the study.
Describe the data and safety monitoring plan developed to ensure the safety of participants as well as
validity and integrity of research data.
This needs to include, when something needs to be reported, the frequency of the monitoring, such as
points in time or after a specific number of participants are enrolled; who will conduct the monitoring, such
as a data monitoring committee, data and safety monitoring board, medical monitor, investigator,
independent physician, the specific data to be monitored; procedures for analysis and interpretation of the
data; actions to be taken upon specific events or end points; and procedures for communication from the
data monitor to this site.
All data collection is considered standard of care and is used to monitor patient safety as a part of standard
care. 
Describe the mechanism for releasing specimens (or other data) for future research.
This includes identifiable information and de-identified information shared with internal and/or external
investigators. (An additional requirement for external investigators would be implementing a Data Use
Agreement.)
N/A
2. 
3. 
4. 
5. 
6. 
7. 
8. 
9. 


10. Blood/Fluid/Tissue Samples
This section is ONLY for repositories collecting blood, fluid, or tissue. SKIP THIS SECTION FOR DATABASE
ONLY STUDIES.
Select the items that are included as part of your study:
Collection of blood, fluid, or tissue 
1. 
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Infectious and zoonotic agents (viruses, bacteria, etc.), biological toxins, or recombinant DNA or
synthetic DNA products 
Blood, Fluid, or Tissue
Describe the blood draw process.
N/A
Specify the amount of blood drawn each time.
N/A
How many times will blood be drawn?
N/A
Where will the blood collection take place?
N/A
If someone other than a phlebotomist or nurse is drawing the blood, please specify who will draw
the blood and any training or certifications the person may have.
N/A
Please list all other tissue, fluid, or body samples that will be obtained for this study.
N/A
Are the samples being collected by a non-invasive technique?
 Yes    No 
Please describe the collection process for all other tissues.
N/A
Are the blood draws and/or collection of fluid/tissue samples being done in an environmental
health and safety (EHS) approved space?
N/A
Access/Storage
Who will have access to the samples?
Please indicate if investigators not listed on this application will have access to the samples, and if so,
what information will be associated with the samples.
N/A
Please describe where and how long the samples will be kept.
N/A
2. 
A. 
B. 
C. 
D. 
E. 
F. 
G. 
H. 
I. 
3. 
A. 
B. 
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11. Sub-forms
Select the items that are included as part of your study.
For items marked, a sub-form will be generated for your completion at the end of this application.
VA participants, VA resources, and/or time of VA personnel 
1. 
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HIPAA Subform
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Requesting a waiver of documentation of consent (no signature) - (Some studies may have a waiver of
documentation and written consent.) 
Requesting a waiver of consent or an alteration of the required elements of consent 
Children (under 18) 
Non-English speaking subjects 
Participants with impaired decision-making capacities (Some subjects maybe temporarily incompetent
due to circumstances or medication. Please checkt this box if the subject population for this study meet
these criteria) 
Pregnant women or fetuses (Check for studies that will enroll pregnant women and there is a potential
for the research to cause harm to the pregnant woman or the unborn fetus. Do not check this box for
survey research.) 
Non-viable neonates or neonates of uncertain viability 
Prisoners 
Costs and/or Compensation (Select this box for subject payments/compensation and costs associated
with the research (including subject costs). 
Access to Health Information (HIPAA) 
The research is sponsored and/or supported by:
US Department of Education 
Department of Energy 
Department of Defense 
Department of Justice 
Environmental Protection Agency 
2. 
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1. HIPAA
HIPAA regulations apply to this research if you select any item listed below.
Check all that apply.
Data are derived from a medical record 
Data are added to the hospital or clinical medical record 
Data are created or collected as part of health care 
Data are used to make health care decisions 
The research is being conducted in a covered entity or at a location where there is patient billing 
If data are derived from a medical record, please identify the source here.
Cerner/EMR; Hospital Coding/Database; Intra-op Entry (OBERD/REDCAP) 
If HIPAA regulations apply, select the form that will be used.
1. 
2. 
3. 
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Waiving Documentation of Consent Subform
Waiver or Alteration of Consent Subform
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HIPAA Authorization 
Waiver of Authorization 
Preparatory to Research 
Limited Data Set 
Data Use Agreement 
For VA research, you must use the:
VA Authorization (if data/specimens are to be removed from the VA, it must be reflected in the
Authorization) 
VA Waiver of Authorization 
VA Preparatory to Research 
4. 
1. Waiving Documentation of Consent
If you are conducting research with more than one subject population, then this form will need to be
completed for each population. Please specify the subject population for this form:
Prospective Patients
Your project must fall under one of the following two criteria for waiving documentation of consent. 
Check the criteria that applies to your study.
Justify how your project meets the criteria for a waiver of documentation.
This is a high volume of patients and allowing them to use OBERD for an electronic consent results in a lower
wait times. 
Instruction: A copy of the consent must be uploaded with your Application for IRB review.
1. 
2. 
 The research presents no more than minimal risk of harm to subjects and involves no procedures for
which written consent is normally required outside of the research context.
 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.
[The study cannot be FDA regulated]
3. 
1. Waiver or Alteration of Informed Consent
If you are conducting research with more than one subject population, then this form will need to be
completed for each population. Please specify the subject population for this form:
Retrospective Subjects
1. 
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Generated at: 12/02/2020 10:20 AM 


Please select the option that you are requesting.
A waiver of consent is being requested. 
Partial waiver (alteration) of consent is being requested. 
Criteria for Waiving or Altering Consent
Provide study specific justification for each of the following:
The research involves no more than minimal risk to participants.
It is strictly a retrospective, chart review, so there will be no change/alteration in patient treatment or
outcome. There will be no identifiable information correlated to the patient information, so there will be
no risk of any possible release of information or HIPAA violation. The information we will be looking for
is already in the medical record. 
The waiver or alteration will not adversely affect the rights and welfare of the participants.
Our site will not release any of this protected information to anyone outside the study team. The site
will destroy the information if the subject does not sign consent and enroll in the study.
The research could not practicably be carried out without the waiver or alteration.
Participants have already had the surgical procedure performed and are no longer being routinely seen
in clinic.
We will be calling them for all future data collection in order to consent them, but for previous data we
are asking for a waiver of consent.
Whenever appropriate, the subjects will be provided with additional pertinent information after
participation (debriefing).
N/A
2. 
3. 
A. 
B. 
C. 
D. 
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