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View: 01. General Study Information
Section: 01. General Study Information
52%
Date: Tuesday, August 10, 2021 2:40:07 PM
01. General Study Information
The forms menu on the left displays all sections and pages of the
application. Pages in bold are required. Pages in italics may not
apply to your project. Use the "Continue" button to advance
through the smartform, as it will only display the sections that
must be completed.
All questions marked with a red asterisk (*) are required.
Questions without a red asterisk may or may not be required,
depending on their relevance to the study.
1.1* Study Title:
Multicenter Perioperative Outcomes Group (MPOG) and Anesthesiology Performance Improvement
and Reporting Exchange (ASPIRE) Performance Site
1.1.1 Full Study Title:
Multicenter Perioperative Outcomes Group (MPOG) and Anesthesiology Performance Improvement
and Reporting Exchange (ASPIRE) Performance Site
1.1.2 If there are other U-M studies related to this project, enter the eResearch ID number
(HUM#) or IRBMED Legacy study number. Examples of related projects include, but are not
limited to:
Projects funded under the same grant
IRBMED Legacy study being migrated into eResearch
Previously approved Umbrella applications (such as Center Grants or approvals for release of
funding)
Previously approved projects for which this is a follow up study
HUM00024166 - Multicenter Perioperative Outcomes Group (MPOG) and Anesthesiology
Performance Improvement and Reporting Exchange (ASPIRE)
1.1.3* Does this application include the study of COVID-19?
For example:
testing or studying the COVID-19 virus,
exploring treatment options,
studying the impact of the COVID-19 pandemic (This could included epidemiological,
social, behavioral, or educational research).
Note: Answer "Yes" only if this project includes the study of COVID-19. Inclusion of study
procedures solely intended to allow the research to be conducted under pandemic constraints,
such as remote interactions with subjects, remote consenting, or at-home drug delivery are not
considered the study of COVID-19.
Yes No
1.2* Principal Investigator:
Sachin Kheterpal
Note: If the user is not in the system, you may Create A New User Account...
1.3 Study Team Members:
Study
Team
Member
Study Team
Role
Appointment
Dept
Appointment
Selection
Complete?
Student Friend
Account
COI
Review
Required
Edit
Rights
Accepted
Role?
PEERRS
Human
Subjects?
Sachin
Kheterpal PI
MM
Anesthesiology
Department
Yes no No no yes N/A yes
Nirav
Shah Co-Investigator
MM
Anesthesiology
Department
Yes no No no yes Yes yes
Victoria
Lacca
Study
Coordinator/Project
Manager
MM
Anesthesiology
Department
Yes no No no yes Yes yes
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Study
Team
Member
Study Team
Role
Appointment
Dept
Appointment
Selection
Complete?
Student Friend
Account
COI
Review
Required
Edit
Rights
Accepted
Role?
PEERRS
Human
Subjects?
Nicole
Eyrich Administrative Staff N/A no No yes N/A yes
Shelley
Vaughn Administrative Staff N/A no No yes N/A yes
1.8* Project Summary:
The Multicenter Perioperative Outcomes Group (MPOG) is a consortium of anesthesiology
departments of academic medical centers with electronic perioperative information systems. The
purpose of MPOG is to allow multi-institutional collaboration for the purpose of accelerating outcomes
research in perioperative medicine. The Anesthesiology Performance Improvement and Reporting
Exchange (ASPIRE) is a sub-group of MPOG and is focused on using data to assess variation in
practice, identify local/regional best practices, measure process adherence and patient outcomes,
create programs for quality improvement, and enable collaboration among anesthesiologists,
surgeons, and CRNAs. ASPIRE will also develop research topics which will lead to quality assurance
research projects.
MPOG was developed so that institutions across the globe can join together to pool their electronic
perioperative data into a common research database. These limited datasets are to be used for
clinical outcomes and quality assurance research purposes by the physicians of the institutions. The
database also includes administrative information and outcomes data from these institutions. MPOG
will have a coordinating center that receives a limited dataset (only date of service will be uploaded
into the repository) which will merge the data into one centralized database.
This IRB is for the University of Michigan to become a performance site for MPOG and ASPIRE to
upload the University of Michigan limited dataset from our anesthesia electronic information systems
to the MPOG coordinating center repository (HUM00024166). MPOG has a Perioperative Clinical
Research Committee (PCRC) which is comprised of members of institutions who are contributing
data. The PCRC serves as the publication committee of MPOG and ASPIRE responsible for
reviewing, refining, and modifying any research proposals and manuscripts created by researchers at
active/contributing institutions. All proposed research studies using data from the central MPOG
database must pass a peer-review process by the PCRC prior to submission for publication.
Patients included will be from all age groups and all medical conditions. There are no exclusions. All
data will be scrubbed for any identifiable information prior to sending to MPOG central repository for
merging into a MPOG database. There will be no patient identifiers stored in the MPOG central
repository and no members of the research team will ever have access to identifiers. Automated
database extraction process will be performed on secure UMHS servers. The only PHI element
collected will be date of service.
1.9* Select the appropriate IRB:
IRBMED
1.11* Estimated Duration of Study:
10 years
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View: VIEW000072_customAttributes._attribute186_Study Team Detail
Section: 01. General Study Information
Study Team Detail
1.4 Team Member:
Sachin Kheterpal
Preferred email: sachinkh@med.umich.edu
Business phone 734-936-4280
Business address: Room 1H247 University Hospital Anesthesiology 48109-5048
1.5 Function with respect to project:
PI
1.6 Allow this person to EDIT the application, including any supporting
documents/stipulations requested during the review process:
Yes
Credentials: Required for PI, Co-Is and Faculty Advisors
Upload or update your CV, resume, or biographical sketch.
Name Version
CV(0.01) 0.01
Conflict of Interest Detail: Required for all roles except Administrative Staff
Current Disclosure Status in M-Inform: This study team member has disclosed outside interest(s)
or relationship(s) in M-Inform.
D1 Do you or your family members have an outside activity, relationship, or interest with a non-UM
entity, where the non-UM entity:
Provides financial or non-financial support for this project;
Supplies a product used in this project (e.g., an app, device, compound, drug, software, survey,
evaluation) either for free or at a cost (e.g., purchased);
Holds an option or license to intellectual property used in this project (e.g., a device, compound,
drug, software, survey, evaluation, code, data, schematics, algorithms) that you or your family
member developed;
Will perform work on this project (e.g., subcontract, service agreement, unfunded agreement);
or
Has a financial stake in the outcome of this research?
No
D2 If “Yes” to the question above, provide the name of the outside entity or entities and a brief
description of the interest/relationship(s):
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View: VIEW000072_customAttributes._attribute186_Study Team Detail
Section: 01. General Study Information
Study Team Detail
1.4 Team Member:
Nirav Shah
Preferred email: nirshah@umich.edu
Business phone 734-936-4280
Business address: Anesthesiology 1H247 UH SPC 5048 48109-5048
1.5 Function with respect to project:
Co-Investigator
1.6 Allow this person to EDIT the application, including any supporting
documents/stipulations requested during the review process:
Yes
1.7 Include this person on all correspondences regarding this application: (Note: This will
include all committee correspondence, decision outcomes, renewal notices, and adverse event
submissions.)
Yes
Credentials: Required for PI, Co-Is and Faculty Advisors
Upload or update your CV, resume, or biographical sketch.
Name Version
NShah_CV_04_20_2020.pdf(0.01) 0.01
Conflict of Interest Detail: Required for all roles except Administrative Staff
Current Disclosure Status in M-Inform: This study team member has indicated in M-inform that
they do not have any outside interests to disclose.
D1 Do you or your family members have an outside activity, relationship, or interest with a non-UM
entity, where the non-UM entity:
Provides financial or non-financial support for this project;
Supplies a product used in this project (e.g., an app, device, compound, drug, software, survey,
evaluation) either for free or at a cost (e.g., purchased);
Holds an option or license to intellectual property used in this project (e.g., a device, compound,
drug, software, survey, evaluation, code, data, schematics, algorithms) that you or your family
member developed;
Will perform work on this project (e.g., subcontract, service agreement, unfunded agreement);
or
Has a financial stake in the outcome of this research?
No
D2 If “Yes” to the question above, provide the name of the outside entity or entities and a brief
description of the interest/relationship(s):
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View: VIEW000072_customAttributes._attribute186_Study Team Detail
Section: 01. General Study Information
Study Team Detail
1.4 Team Member:
Victoria Lacca
Preferred email: lacca@umich.edu
Business phone 734-936-8081
Business address: Anesthesiology 1H247 UH SPC 5048 48109-5048
1.5 Function with respect to project:
Study Coordinator/Project Manager
1.6 Allow this person to EDIT the application, including any supporting
documents/stipulations requested during the review process:
Yes
1.7 Include this person on all correspondences regarding this application: (Note: This will
include all committee correspondence, decision outcomes, renewal notices, and adverse event
submissions.)
Yes
Credentials: Required for PI, Co-Is and Faculty Advisors
Upload or update your CV, resume, or biographical sketch.
Name Version
There are no items to display
Conflict of Interest Detail: Required for all roles except Administrative Staff
Current Disclosure Status in M-Inform: This study team member has not yet disclosed in M-
Inform.
D1 Do you or your family members have an outside activity, relationship, or interest with a non-UM
entity, where the non-UM entity:
Provides financial or non-financial support for this project;
Supplies a product used in this project (e.g., an app, device, compound, drug, software, survey,
evaluation) either for free or at a cost (e.g., purchased);
Holds an option or license to intellectual property used in this project (e.g., a device, compound,
drug, software, survey, evaluation, code, data, schematics, algorithms) that you or your family
member developed;
Will perform work on this project (e.g., subcontract, service agreement, unfunded agreement);
or
Has a financial stake in the outcome of this research?
D2 If “Yes” to the question above, provide the name of the outside entity or entities and a brief
description of the interest/relationship(s):
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View: VIEW000072_customAttributes._attribute186_Study Team Detail
Section: 01. General Study Information
Study Team Detail
1.4 Team Member:
Nicole Eyrich
Preferred email: nipescat@umich.edu
Business phone 734-936-4071
Business address: Anesthesiology Department 2800 Plymouth Road 48109-2800
1.5 Function with respect to project:
Administrative Staff
1.6 Allow this person to EDIT the application, including any supporting
documents/stipulations requested during the review process:
Yes
1.7 Include this person on all correspondences regarding this application: (Note: This will
include all committee correspondence, decision outcomes, renewal notices, and adverse event
submissions.)
Yes
Credentials: Required for PI, Co-Is and Faculty Advisors
Upload or update your CV, resume, or biographical sketch.
Name Version
There are no items to display
Conflict of Interest Detail: Required for all roles except Administrative Staff
Current Disclosure Status in M-Inform: This study team member has not yet disclosed in M-
Inform.
D1 Do you or your family members have an outside activity, relationship, or interest with a non-UM
entity, where the non-UM entity:
Provides financial or non-financial support for this project;
Supplies a product used in this project (e.g., an app, device, compound, drug, software, survey,
evaluation) either for free or at a cost (e.g., purchased);
Holds an option or license to intellectual property used in this project (e.g., a device, compound,
drug, software, survey, evaluation, code, data, schematics, algorithms) that you or your family
member developed;
Will perform work on this project (e.g., subcontract, service agreement, unfunded agreement);
or
Has a financial stake in the outcome of this research?
D2 If “Yes” to the question above, provide the name of the outside entity or entities and a brief
description of the interest/relationship(s):
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View: VIEW000072_customAttributes._attribute186_Study Team Detail
Section: 01. General Study Information
Study Team Detail
1.4 Team Member:
Shelley Vaughn
Preferred email: mhousey@umich.edu
Business phone 734-936-5334
Business address: North Campus Research Complex Bldg 16 Rm 018W 48109-2435
1.5 Function with respect to project:
Administrative Staff
1.6 Allow this person to EDIT the application, including any supporting
documents/stipulations requested during the review process:
Yes
1.7 Include this person on all correspondences regarding this application: (Note: This will
include all committee correspondence, decision outcomes, renewal notices, and adverse event
submissions.)
Yes
Credentials: Required for PI, Co-Is and Faculty Advisors
Upload or update your CV, resume, or biographical sketch.
Name Version
Housey_Resume(0.02) 0.02
Conflict of Interest Detail: Required for all roles except Administrative Staff
Current Disclosure Status in M-Inform: This study team member has not yet disclosed in M-
Inform.
D1 Do you or your family members have an outside activity, relationship, or interest with a non-UM
entity, where the non-UM entity:
Provides financial or non-financial support for this project;
Supplies a product used in this project (e.g., an app, device, compound, drug, software, survey,
evaluation) either for free or at a cost (e.g., purchased);
Holds an option or license to intellectual property used in this project (e.g., a device, compound,
drug, software, survey, evaluation, code, data, schematics, algorithms) that you or your family
member developed;
Will perform work on this project (e.g., subcontract, service agreement, unfunded agreement);
or
Has a financial stake in the outcome of this research?
D2 If “Yes” to the question above, provide the name of the outside entity or entities and a brief
description of the interest/relationship(s):
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View: 01-1. Application Type
Section: 01. General Study Information
01-1. Application Type
1-1.1* Select the appropriate application type.
Application Type Description
Human Subjects research
involving interaction or
intervention (formerly Standard,
non-exempt research project - or
- Exempt)
Studies that involve either or both of the
following:
Interaction, including communication or
interpersonal contact between investigator
and subject
Intervention, including both physical
procedures by which information or
biospecimens are gathered (e.g.,
venipuncture) and manipulations of the
subject or subject’s environment that are
performed for research purposes
Interaction/Intervention studies may also have a
"secondary research" component.
Does the research involve any of the following:
a. more than minimal risk to participants?
b. use of drugs or medical devices?
c. target prisoners as research subjects?
d. collection of biospecimens from subjects (including blood, saliva, cheek
swabs)?
Yes No
Secondary research uses of
private information or
biospecimens
"Secondary research" are studies that involve
ONLY re-using private information and/or
biospecimens that are collected for some other
"primary" or "initial" activity, such as other earlier
research studies, a biorepository holding
specimens obtained with "broad consent,"
clinical care, or educational records. Includes
Exemption 4 and “not regulated” projects.
Do NOT use this application type for:
Studies that also have an
interaction/intervention component, such
as primary collection of information or
biospecimens for the purposes of the
study. (Choose instead "Human subjects
research involving interaction or
intervention.")
Projects involving secondary use of
information/biospecimens for only non-
research purposes, such as QA/QI, case
studies on one or two individuals, or use
in a class to teach research methods.
(Choose instead "Activities not regulated
as human subjects research.")
Activities Not Regulated as
human subjects research
Not all activities that involve people, their data, or
specimens are covered by the regulations
governing human subjects research (45 CFR 46
or 21 CFR 50/56).
IRB review is required for the following
activities ONLY to assess compliance with
HIPAA or other regulations or institutional
policies:
Research on existing data or specimens
that have been coded before the
researcher receives them, but identifiers
still exist.
Research Involving Deceased Individuals
Only
Pre-review of Clinical Data Sets
Preparatory to Research
Standard Public Health Surveillance or
Prevention Activities
IRB review is not required for the following
activities, but researchers may wish complete
this brief application to generate a determination
letter for funding or publication purposes, or to
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request IRB review to confirm the “Not
Regulated” determination:
Case Studies
Class Activities
Journalism/Documentary Activities
Oral History
Quality Assurance and Quality
Improvement Activities
Research on Organizations
Research using Publicly Available Data
Sets
Projects lacking immediate
plans for involvement of
human subjects, their data,
and/or their specimens
Activities such as training grants, program
projects, center grants, or multi-phase studies
not involving human subjects until later years.
Before release of funding, some agencies may
require IRB acknowledgement of the future use
of human subjects.
These projects are sometimes referred to as
"umbrella projects" or "dry applications."
Single-patient Expanded
Access Drug or Biologic
(Emergency Use or Non-
Emergency/Compassionate
Use)
Use of an investigational drug or biologic,
outside of a clinical trial, under a single-patient
IND issued by the FDA for a patient faced with a
serious or life-threatening disease or condition.
Contact the IRB Chair-on-Call as soon as
possible once the decision to use the
investigational drug or biologic is made.
Submission for IRB review and approval
is required, prior to use if feasible. If this
was an emergency use, submit no later
than five days after use of the
investigational agent.
This includes both one-time use and
continuing therapy.
Single-patient Expanded
Access Device Use
(Emergency Use or Non-
Emergency/Compassionate
Use)
Use of an investigational device, outside of a
clinical trial, when this is the only option available
for a patient faced with a serious or life-
threatening disease or condition.
Contact the IRB Chair-on-Call as soon as
possible once the decision to use the
investigational device is made.
Submission for IRB review and approval
is required, prior to device use if feasible.
If this was an emergency use, submit
no later than five days after use of the
investigational device.
This includes both one-time use and
continuing therapy.
Humanitarian Use Device
(HUD) under a HDE
Non-research, on-label use of an HUD under a
Humanitarian Device Exemption (HDE)
Requesting Review by a Non-UM
IRB
Use ONLY to request deferral of IRB oversight
for UM activities to a non-UM IRB or when UM is
a performance site in a multisite research project
where UM is the lead site.
Multi-site Research where U-M
is a Coordinating Center and/or
IRB of Record
Do not use Multi-site Research application type
when U-M is only a performance site - select
Standard application type.
Select when U-M is any of the following:
Data Coordinating Center;
Clinical Coordinating Center; or
IRB of Record for non-U-M sites (for U-M
to be IRB of Record you must contact
your IRB for prior acknowledgement).
When U-M is also a performance site, a
separate application is required for local site
considerations.
Refer to special requirements at the IRB website.
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View: 01-2. Standard Study Information
Section: 01. General Study Information
01-2. Standard Study Information
1-2.1* Who initiated this study?
Investigator
1-2.2* Are you or any students working on this project being paid from a federally funded
training grant?
Yes No
1-2.3 This study is currently associated with the following department. To associate this
research with a different department, click Select. If the department has defaulted to "student",
click select to specify the department through which this application is being submitted.
MM Anesthesiology Department
1-2.4 Will the study utilize resources from the following centers?
Select all that apply:
There are no items to display
1-2.5* Is the study related to cancer, cancer risk, or cancer care delivery?
Yes No
1-2.6* Does this study require review by the Rogel Cancer Center Protocol Review
Committee (PRC)?
Yes No
1-2.7* Has the scientific merit of this study already been peer reviewed (i.e., reviewed by one
or more recognized authorities on the subject)?
Yes No
1-2.7.1* List the peer-review organization(s).
Peer Review Organization
Other (explain below)
The MPOG Perioperative Clinical Research Committee (PCRC) will review all research proposals for
scientific validity.
1-2.8* Is this a clinical trial?
Yes No
1-2.9* Would the integrity of this research study be compromised if the subject were able to
view results of their research tests or medications in the Patient Portal of MyUofMHealth.org?
Research results displayed to the subject in MyUofMHealth.org will include: lab results,
radiology examinations and outpatient medication lists. Contracts and protocols should be
assessed by the Principal Investigator for specific language regarding blinding of subjects and
their research results.
(NOTE: Additional actions are required in order to limit the subject’s view into their electronic
medical record. Contact the IRB for additional information or see additional guidance for
blinded studies at https://az.research.umich.edu/medschool/guidance/guidance-blinded-studies)
Yes No
1-2.10* Does the study involve administration of a cell therapy product?
Yes No
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View: 02. Sponsor/Support Information
Section: 02. Sponsor/Support Information
02. Sponsor/Support Information
The following sections request details about the current or pending sponsorship/support of this study.
Consider all of the choices below and complete the appropriate sections.
* Note: At least one of the following sections must be answered. Multiple forms of funding or support
must be added one at a time.
2.1 Please select all Proposal Approval Forms (PAFs), Awards (AWDs), and/or Unfunded Agreements (UFAs) associated
with this study.
Click here to indicate that a PAF(s) has not been initiated.
Related PAFs:
ID Title PI Direct Sponsor Prime Sponsor State Has SUBKs? Related Awards
There are no items to display
Related AWDs:
Award ID Title PI Direct Sponsor Prime Sponsor State Has SUBKs? Project Period Awarded PAFs
There are no items to display
Related UFAs:
UFA ID Title PI State Category Start Date End Date
There are no items to display
2.2 Internal UM Sponsor(s)/Support: [Including department or PI discretionary funding]
Type Department Sponsor Support Type
There are no items to display
2.3 Check here if the proposed study does not require external or internal sponsorship or
support:
2.4* Is there any other financial or non-financial sponsorship or support not covered in the
sections above?
Yes No
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View: 03. UM Study Functions
Section: 03. Performance Sites
03. UM Study Functions
3.1* Indicate all functions that will be performed at University of Michigan locations.
Select all that apply:
Secondary data collection (e.g., medical chart review, data abstraction from existing records, etc.)
Primary or secondary analysis (data/specimen)
Storage (data and/or specimen): Responsible for the management, security and transfer of study data
and/or specimens.
Other
If other, please specify.
UM is both the clinical coordinating center and an enrolling site. A separate application exists as UM
as a coordinating site (HUM00024166).
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View: 03-1. Performance Sites
Section: 03. Performance Sites
03-1. Performance Sites
3-1.1* Performance Sites:
Location Country "Engaged" in the
research?
Performance
Site Type Site Function
University of
Michigan USA yes Storage,Other,Analysis,Secondary
data collection
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View: Performance Site Detail
Section: 03. Performance Sites
Performance Site Detail
3-1.2* Location or Institution:
University of Michigan
3-1.3 Address:
City
State
Country*USA
3-1.4* Function of this location with respect to this study:
Select all that apply:
Secondary data collection (e.g., medical chart review, data abstraction from existing records, etc.)
Primary or secondary analysis (data/specimen)
Storage (data and/or specimen): Responsible for the management, security and transfer of study data
and/or specimens.
Other
If other, please specify:
UM is both the clinical coordinating center and an enrolling site. A separate application exists as UM
as a coordinating site (HUM00024166).
3-1.5* Will this site be "engaged" in the conduct of the research?
Yes No
3-1.6 If known, provide the Federalwide Assurance (FWA) number for this location.
FWA00004969
3-1.7 If applicable, indicate what organization, agency or government office has reviewed this
research and provided its approval (e.g., IRB, ethics committee, school district office, prison
official, nursing home administrator).
3-1.8 Upload any location site approval documentation here:
Name Version
There are no items to display
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View: 05. Research Design
Section: 05. Research Design
05. Research Design
5.1* Is there a stand-alone scientific protocol document and/or research plan associated with
this application?
Yes No
5.1.1* Click ADD to attach the document(s) electronically.
Name Version
MPOG Performance Site IRB(0.01) 0.01
5.1.2* Indicate the section where each of the following are covered in the attached protocol:
Objective Please see the Objective section in the protocol.
Specific Aim/Hypothesis Please see the Specific Aims section in the protocol.
Background Information Please see the Background section in the protocol.
Methodology Please see the Methodology section in the protocol.
Statistical Design Please see the Statistical Design section in the protocol.
5.1.3* Study team Experience: Briefly outline the experience and competence of the study
team to pursue the proposed study.
Dr. Kheterpal is a Professor in the Department of Anesthesiology with expertise in perioperative
clinical outcomes research. He has served as a systems designer, database architect, and data
warehouse architect for over 15 years, creating a deep information technology and clinical informatics
knowledgebase. He has previously used retrospective analysis of clinical documentation databases to
publish studies in leading peer-reviewed anesthesiology journals. In addition, he has served as a
representative to the anesthesia patient safety foundation.
Dr. Shah is an assistant professor in the Department of Anesthesiology with expertise in medical
informatics and quality. He is the Director of Informatics and Systems Integration for the Department of
Anesthesiology and the University of Michigan Health System. He has served as a systems designer,
database architect both in industry and at academic institution for over 10 years. He brings a technical
and medical background that will help to integrate the software and analytic system.
5.2* Will the involvement of ANY subjects in this study be limited to analysis of their existing
data or specimens?
Yes No
5.2.1* How many subjects are represented in the data or specimens to be analyzed?
99999999(do not enter commas, dots, or special characters)
5.3* Will the study involve recruitment and/or participation of subjects in order to produce new
data (e.g., surveys, interaction, intervention)? [Require sections 8-1 and 11-3]
Yes No
5.4* List the inclusion and exclusion criteria for this study population and/or data set. (If
covered in attached protocol, indicate section)
Inclusion: All adult and pediatric patients undergoing perioperative services at the University of
Michigan Health System. There are no exclusion criteria.
5.5 Identify any racial, ethnic, or gender group(s) that will be specifically excluded from
participation in this research study and provide a compelling justification for such exclusion:
None
5.6* Indicate the age range (in years) of the subject population in this study.
Minimum Age: 0
Maximum Age: 999If no upper limit, enter "999"
5.8* The primary risk of conducting research with secondary data or specimens is a breach of
confidentiality or privacy, which may cause psychological, social/reputation, legal, or financial
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harm. Indicate any risks to subjects other than these risks from a breach of confidentiality or
privacy. If there are none, answer “none.”
None
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View: 10. Informed Consent - Secondary Use
Section: 10. Informed Consent
10. Informed Consent - Secondary Use of Existing Data/Records/Specimens
Completion of this section is required based on the response provided to questions 1-1.1, 5.2 and 5.3.
10.3* What type of informed consent will be obtained from subjects for the use of their data,
records and/or specimens?
Select all that apply:
Request for waiver of informed consent/parental permission/legally authorized representative consent
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View: 10-3. Informed Consent Waiver
Section: 10. Informed Consent
10-3. Informed Consent Waiver
10-3.1* This request is for:
Select all that apply:
Waiver – General - ALL of the project
10-3.1.1 If this request is for PART of the project, identify the specific research procedures
(e.g., screening interview) and/or the specific subject populations (e.g., parents of child-
subjects) involved.
10-3.1.2 Explain any requested alterations to the informed consent process.
10-3.2* Check below to affirm that this study meets each of the criteria for waiver or alteration
of informed consent and explain how:
(i) The research involves no more than minimal risk to the subjects.
Explain
Clinical / Physical / psychological / social / reputation / financial Risk
- Likelihood: None
- There will be no care interventions, no process changes, no documentation changes, and no
alterations to a patient's clinical experience. Providers will not experience any changes in their roles,
responsibilities, or care. A limited dataset will be extracted months AFTER the clinical care episode is
complete. The database servers employed are not production servers and no application
performance changes will be experienced
Privacy Risk
- Likelihood: None to Extremely Rare
- Theoretically, since patient data is being extracted, there exists a non-zero privacy risk. However,
since the data extraction process is automated and the data structures involved separate patient
identifiers from the data being extracted, the likelihood is EXTREMELY rare. Patient identifiers (DOB,
Name, MRN, Insurance account numbers, SSN) are NOT stored or transmitted at any point during
the data extraction or transmittal process.
- To further mitigate this risk, all data extraction processes are automated to eliminate the possibility
of human error. No research personnel are required to 'match' or review identifiers.
- All database work is performed on UMHS-MCIT approved and secured servers that are physically
located in the UMHS computing environment and maintained by MCIT security standards
- No patient identifiers will ever be stored or transported on portable computing devices (laptops, USB
drives, CD, DVD, etc) that can be lost or misplaced
(ii) Research could not practicably (i.e., feasibly) be carried out without the waiver or alteration.
Explain
There are two major reasons the research would not be feasible:
1) selection bias introduced by a consenting or opt-out process. Because of the low frequency nature
of the events being studied, the selection bias introduced by a signed informed consent or
informational sheet would make the research impossible to perform. For example, some of the events
we hope to study have an incidence of 0.16% and require the collection of data on 15,000 patients to
observe only 37 events. A single patient opting out would significantly impact the ability to gain new
knowledge in such clinical areas. More importantly, the patients most likely to opt out may be focus of
specific rare event research (eg, uncontrolled postoperative pain in chronic pain patients)
2) Secondly, it is not practicable to consent the hundreds of thousands of patients required to study
these conditions. Acquiring written consent, documentation of consent, or opt-out capability for
several hundred thousand patients would eliminate the ability to perform research on these low-
frequency events. Because it is unknown which patients will have an event prior to the event
occuring, all perioperative patients must be included in the dataset. The events and situations being
evaluated are often extremely low incidence (ie, < 1%), making prospective enrollment prohibitive.
The infrastructure necessary to manage even a simple informational sheet / addition to surgical
consent would be massive and manual. If the patient has the ability to opt-out (assumed if there is an
informational sheet / surgical consent change), then a manual process to record the medical record
number, date of service, etc would have to be created. Study personnel would have to deployed 24 x
7 in the operative suite (since all surgeries are being evaluated) and a manual process to record the
opt-outs would have to be funded. Furthermore, the manual recording of opt-outs would increase the
privacy risk of the patient.
(iii) If the research involves identifiable private information or biospecimens, the research could
not be practicably carried out without using such information or biospecimens in an identifiable
format.
Explain
The only identifiers in the MPOG repository are the date-of-service. No other PHI is included.
(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects.
Explain
The welfare of the patient is not be adversely affected whatsoever.
The rights of the patient will not be adversely affected because the risk of the right to privacy is
extremely low. In fact, creating an informed consent (written or informational sheet) process would
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invariably decrease the patient's right to privacy and welfare. As currently proposed, no research
personnel would ever access or use the patient identifiers or information. The patient would be
completely unaffected by the conduct of the study.
If an informed consent or opt-out process were required, then research personnel would need access
to the patients name, reg num, operation, diagnoses, etc. The risk of privacy loss would INCREASE
due to the consenting / opt-out process rather than decrease. Maintaining a list of patients that opted-
out would require the storage of their identifiers in either paper or electronic format. The privacy risk
would increase as a result.
(v) Whenever appropriate, the subjects or their Legally Authorized Representative will be
provided with additional pertinent information after participation.
Explain
NA. The information will be useful for future surgical patients, not for a specific patient.
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View: 11. Confidentiality/Security/Privacy
Section: 11. Confidentiality, Security and Privacy
11. Confidentiality/Security/Privacy
11.1* Will the study team access any data that is linked to a subject's identity by name or other
identifier or code? [Require Section 11-1]
Yes No
11.2* Explain how the subjects' privacy will be protected.
- Theoretically, since patient data is being extracted, there exists a non-zero privacy risk. However,
since the data extraction process is automated and the data structures involved separate patient
identifiers from the data being extracted, the likelihood is EXTREMELY rare. Patient identifiers (DOB,
Name, MRN, Insurance account numbers, SSN) are NOT stored or transmitted at any point during the
data extraction or transmittal process.
- To further mitigate this risk, all data extraction processes are automated to eliminate the possibility of
human error. No research personnel are required to 'match' or review identifiers.
- All database work is performed on UMHS-MCIT approved and secured servers that are physically
located in the UMHS computing environment and maintained by MCIT security standards
- No patient identifiers will ever be stored or transported on portable computing devices (laptops, USB
drives, CD, DVD, etc) that can be lost or misplaced
The statisticians, clinical researchers, and manuscript writers will not have access to the protected
health information. Only a limited dataset (only identifier will be date-of-service) will be stored or sent
to the coordinating center. Centralized resources would never be able to identify a specific patient.
11.3* How will the study team protect research records, data, and/or specimens against
inappropriate use or disclosure, or malicious or accidental loss or destruction in order to
protect the confidentiality of subject data?
Select all that apply:
Restricted access
Destruction of source data immediately after data collection (e.g., to preserve anonymity of a
vulnerable population)
Access rights terminated when authorized users leave the project or unit
Individual ID plus password protection
Routine electronic back up
Encryption of digital data
Network restrictions
Security software (firewall, anti-virus, anti-intrusion) is installed and regularly updated on all servers,
workstations, laptops, and other devices used in the project
Safe disposition/destruction of data or devices, as appropriate (e.g., shredding paper documents,
destroying disks or thumb drives, secure erasure of electronic media)
If other please specify:
11.4* Does either statement apply to this research:
Research has NIH, CDC, or FDA funding, or other federal funding from an agency that
automatically issues a Certificate of Confidentiality as part of the terms of the award:
The study will include identifiable sensitive information, identifiable biospecimens, individual human-
level genomic data/biospecimens, or any information about an individual for which there is at least a
very small risk, as determined by current scientific practices or statistical methods, that some
combination of the information, a request for the information, and other available data sources could
be used to deduce the identity of an individual.
or
Research does NOT have NIH, CDC, or FDA funding, or other federal funding from an agency
that automatically issues a Certificate of Confidentiality as part of the terms of the award:
The study will include identifiable, sensitive information or identifiable biospecimens that, if revealed,
might place the subjects at risk for personal safety, criminal or civil liability, or damage to their financial
standing, employability, insurability, or reputation.
[Require Section 11-2]
Yes No
11.5* Will data be provided to a repository as part of a data sharing agreement?
Yes No
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11.6* What will happen to the data and/or any specimens at the conclusion of this study?
Select all that apply:
Destroy
11.6.1* If the data and/or specimens will be destroyed, describe the specific plan that will be
employed following the required retention period.
The identifiers will be removed during the data collection process and will be absent at the conclusion
of the study and during the statistical analysis phase.
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View: 11-1. Identifiable Data
Section: 11. Confidentiality, Security and Privacy
11-1. Identifiable Data
Completion of this section is required based on the response provided to question 11.1.
11-1.1* Indicate how subjects are identified in the research records.
Select all that apply:
Coded or Indirect Identifiers - data record includes a link to direct identifiers (e.g., name, initials,
phone number, SSN, or medical record number linked to data record but stored separately)
11-1.2* Explain the necessity for collecting or maintaining data linked to subjects' identities. If
the information is covered in the attached protocol, please indicate section.
In order to combine disparate electronic data sources, the automated data extraction processes will
use MRN (medical record number) and date of surgery to merge data. Laboratory, financial,
perioperative CIS, outcome registry data is being merged together using an automated process that
does NOT reveal PHI to any human or require manual data aggregation.
Once the query is completed, NO identifier information is retrieved, stored, or used. The only PHI
element stored is date of surgery. This is essential to enable research into variation in quality by day of
week or season of year.
Once the data are extracted from the source database, all identifiers are removed and destroyed and
cannot be recreated
Only the database mining automated processes will have visibility to the patient identifier and not the
statistical team, manuscript authors, or any members of coordinating center.
11-1.3* How long will the identifiers be retained?
The identifiers will not be retained. They will be accessed in the source databases (data warehouse,
perioperative CIS, etc) during the query process, but not stored in the research database extract itself.
11-1.4* Will individually identifiable sensitive data be accessed, collected, used, maintained, or
disclosed in the study?
Yes No
11-1.4.1* Will a continuous, periodic, or automatic feed of sensitive data be set up to provide
data directly from any University information system (e.g., M-Pathways, U-M Data Warehouse,
CareWeb)?
Yes No
11-1.4.2* Will sensitive data be accessed by individuals who are not University employees?
Yes No
11-1.4.3* Will sensitive data be stored on or accessed from computer equipment that is not
maintained and supported by a University IT services provider (e.g., ITS, MCIT, MSIS) - such as
home computers, grant-funded computers, etc.?
Yes No
11-1.4.4* Will sensitive data be stored on portable devices (e.g., laptops, PDAs, flash drives) in
unencrypted form?
Yes No
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View: 24. Secondary Data Analysis
Section: 24. Secondary Data Analysis
24. Secondary Data Analysis
Completion of this section is required based on the response provided to either question 1-1.2.1, 4-1.1
or 7.2.
24.1* List each pre-existing data set that will be used in the study.
Name Identifying Info
Centricity
Clinical
Information
System
This data set includes clinical data entered by clinicians and aggregated from
automated interfaces. Subject identifiers are used since this is our electronic medical
record for the peri-operative process. For a current data dictionary, please see our
concept browser tool (https://mpog.org/concept-browser/) and phenotype list
(https://collations.mpogresearch.org/Collations.aspx?type=general&query=na).
Collaborative
Quality
Initiative
Registries
CQI registries include: Michigan Surgical Quality Collaborative (MSQC), Michigan
Trauma Quality Improvement Program (MTQIP), Michigan Urological Surgery
Improvement Collaborative (MUSIC), Michigan Arthroplasty Registry Collaborative
Quality Initiative (MARCQI), Blue Cross Blue Shield of Michigan Cardiovascular
Consortium (BMC2), Michigan Society of Thoracic and Cardiovascular Surgeons
(MSTCVS), Michigan Bariatric Surgery Collaborative (MBSC), Michigan Spine Surgery
Improvement Collaborative (MSSIC), Obstetrics Initiative (OBI), Michigan Value
Collaborative (MVC). Data dictionaries for these registries are listed in section 24.5. The
data dictionary for BMC2 can be found in the following sites: https://bmc2.org/pci-data-
collection and https://bmc2.org/vs-data-collection. The most current data dictionary for
MTQIP is listed in: https://www.mtqip.org/node/32/#data-dictionary.
National
Surgical
Quality
Improvement
Program
Elements include preoperative comorbidities, laboratory values, procedural information,
provider information, intraoperative information,and 30 day outcomes. Patient identifiers
are used and stored. The data dictionary for this data set is continuously updated - to
view the most recent and all other versions of this data dictionary, please visit
https://www.facs.org/quality-programs/acs-nsqip/participant-use
Society of
Thoracic
Surgeons
Database
This data set includes patient comorbidities, operative characteristics and techniques,
surgical and patient outcome. The data set is continuously updated - to view the most
recent and all other versions of the data dictionary please see the Adult Cardiac
Surgery Database Data Collection (https://www.sts.org/registries-research-center/sts-
national-database/adult-cardiac-surgery-database/data-collection) and General
Thoracic Surgery Database Data Collection (https://www.sts.org/registries-research-
center/sts-national-database/general-thoracic-surgery-database/data-collection)
UMHS Data
Warehouse
Financial charges, reimbursements for professional and facility fees. Also contains date
of death, basic demographic information, and specialty specific databases: trauma
registry, percutaneous coronary intervention, pulmonary function testing, electronic
order entry orders and medication administration. Please see section 24.5 for examples
of data elements contained in this data set.
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View: VIEW000614_customAttributes._attribute232.customAttributes._attribute0_Secondary Data Set Detail
Section: 24. Secondary Data Analysis
Secondary Data Set Detail
24.2* Name, source, and location of data set. ALSO, describe how you gain access to the data
set.
Centricity Clinical Information System
24.3* Describe the type of information contained in the data set, including any potential
subject identifiers.
If a data dictionary is uploaded in 24.5 or included in a separate protocol, refer to it here.
This data set includes clinical data entered by clinicians and aggregated from automated interfaces.
Subject identifiers are used since this is our electronic medical record for the peri-operative process.
For a current data dictionary, please see our concept browser tool (https://mpog.org/concept-browser/)
and phenotype list (https://collations.mpogresearch.org/Collations.aspx?type=general&query=na).
24.4* Please confirm whether the investigators receive or record identifiers from THIS dataset.
Select all that apply:
Direct Identifiers - stored on data record (e.g. name, initials, phone number, SSN, or medical number
stored on data record)
24.5 Upload
Any applicable Data Use or Data Sharing Agreement(DUA/DSA) - unsigned template is
acceptable. Upload is not necessary if this application refers to an Unfunded Agreement (UFA)
in eResearch Proposal Management.
Data dictionary/data collection sheet/list of data variables to be accessed or received by
study team and recorded for analysis. Upload is not necessary if the variables are fully
described in 24.3 or in a separate protocol.
Name Version
There are no items to display
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View: VIEW000614_customAttributes._attribute232.customAttributes._attribute0_Secondary Data Set Detail
Section: 24. Secondary Data Analysis
Secondary Data Set Detail
24.2* Name, source, and location of data set. ALSO, describe how you gain access to the data
set.
Collaborative Quality Initiative Registries
24.3* Describe the type of information contained in the data set, including any potential
subject identifiers.
If a data dictionary is uploaded in 24.5 or included in a separate protocol, refer to it here.
CQI registries include: Michigan Surgical Quality Collaborative (MSQC), Michigan Trauma Quality
Improvement Program (MTQIP), Michigan Urological Surgery Improvement Collaborative (MUSIC),
Michigan Arthroplasty Registry Collaborative Quality Initiative (MARCQI), Blue Cross Blue Shield of
Michigan Cardiovascular Consortium (BMC2), Michigan Society of Thoracic and Cardiovascular
Surgeons (MSTCVS), Michigan Bariatric Surgery Collaborative (MBSC), Michigan Spine Surgery
Improvement Collaborative (MSSIC), Obstetrics Initiative (OBI), Michigan Value Collaborative (MVC).
Data dictionaries for these registries are listed in section 24.5. The data dictionary for BMC2 can be
found in the following sites: https://bmc2.org/pci-data-collection and https://bmc2.org/vs-data-
collection. The most current data dictionary for MTQIP is listed in:
https://www.mtqip.org/node/32/#data-dictionary.
24.4* Please confirm whether the investigators receive or record identifiers from THIS dataset.
Select all that apply:
No Identifiers (De-identified, Anonymous, or Anonymized) - stored data record is stripped of all
identifiers
24.5 Upload
Any applicable Data Use or Data Sharing Agreement(DUA/DSA) - unsigned template is
acceptable. Upload is not necessary if this application refers to an Unfunded Agreement (UFA)
in eResearch Proposal Management.
Data dictionary/data collection sheet/list of data variables to be accessed or received by
study team and recorded for analysis. Upload is not necessary if the variables are fully
described in 24.3 or in a separate protocol.
Name Version
MARCQI Data Dictionary(0.01) 0.01
MBSC Data Dictionary(0.01) 0.01
MSQC Data Dictionary(0.01) 0.01
MSSIC Data Dictionary(0.01) 0.01
MSTCVS Data Dictionary - 1(0.01) 0.01
MSTCVS Data Dictionary - 2(0.01) 0.01
MUSIC Data Dictionary(0.01) 0.01
MVC Data Dictionary - 1(0.01) 0.01
MVC Data Dictionary - 2(0.01) 0.01
OBI Data Dictionary(0.01) 0.01
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View: VIEW000614_customAttributes._attribute232.customAttributes._attribute0_Secondary Data Set Detail
Section: 24. Secondary Data Analysis
Secondary Data Set Detail
24.2* Name, source, and location of data set. ALSO, describe how you gain access to the data
set.
National Surgical Quality Improvement Program
24.3* Describe the type of information contained in the data set, including any potential
subject identifiers.
If a data dictionary is uploaded in 24.5 or included in a separate protocol, refer to it here.
Elements include preoperative comorbidities, laboratory values, procedural information, provider
information, intraoperative information,and 30 day outcomes. Patient identifiers are used and stored.
The data dictionary for this data set is continuously updated - to view the most recent and all other
versions of this data dictionary, please visit https://www.facs.org/quality-programs/acs-
nsqip/participant-use
24.4* Please confirm whether the investigators receive or record identifiers from THIS dataset.
Select all that apply:
Direct Identifiers - stored on data record (e.g. name, initials, phone number, SSN, or medical number
stored on data record)
24.5 Upload
Any applicable Data Use or Data Sharing Agreement(DUA/DSA) - unsigned template is
acceptable. Upload is not necessary if this application refers to an Unfunded Agreement (UFA)
in eResearch Proposal Management.
Data dictionary/data collection sheet/list of data variables to be accessed or received by
study team and recorded for analysis. Upload is not necessary if the variables are fully
described in 24.3 or in a separate protocol.
Name Version
There are no items to display
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View: VIEW000614_customAttributes._attribute232.customAttributes._attribute0_Secondary Data Set Detail
Section: 24. Secondary Data Analysis
Secondary Data Set Detail
24.2* Name, source, and location of data set. ALSO, describe how you gain access to the data
set.
Society of Thoracic Surgeons Database
24.3* Describe the type of information contained in the data set, including any potential
subject identifiers.
If a data dictionary is uploaded in 24.5 or included in a separate protocol, refer to it here.
This data set includes patient comorbidities, operative characteristics and techniques, surgical and
patient outcome. The data set is continuously updated - to view the most recent and all other versions
of the data dictionary please see the Adult Cardiac Surgery Database Data Collection
(https://www.sts.org/registries-research-center/sts-national-database/adult-cardiac-surgery-
database/data-collection) and General Thoracic Surgery Database Data Collection
(https://www.sts.org/registries-research-center/sts-national-database/general-thoracic-surgery-
database/data-collection)
24.4* Please confirm whether the investigators receive or record identifiers from THIS dataset.
Select all that apply:
Direct Identifiers - stored on data record (e.g. name, initials, phone number, SSN, or medical number
stored on data record)
24.5 Upload
Any applicable Data Use or Data Sharing Agreement(DUA/DSA) - unsigned template is
acceptable. Upload is not necessary if this application refers to an Unfunded Agreement (UFA)
in eResearch Proposal Management.
Data dictionary/data collection sheet/list of data variables to be accessed or received by
study team and recorded for analysis. Upload is not necessary if the variables are fully
described in 24.3 or in a separate protocol.
Name Version
There are no items to display
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View: VIEW000614_customAttributes._attribute232.customAttributes._attribute0_Secondary Data Set Detail
Section: 24. Secondary Data Analysis
Secondary Data Set Detail
24.2* Name, source, and location of data set. ALSO, describe how you gain access to the data
set.
UMHS Data Warehouse
24.3* Describe the type of information contained in the data set, including any potential
subject identifiers.
If a data dictionary is uploaded in 24.5 or included in a separate protocol, refer to it here.
Financial charges, reimbursements for professional and facility fees. Also contains date of death,
basic demographic information, and specialty specific databases: trauma registry, percutaneous
coronary intervention, pulmonary function testing, electronic order entry orders and medication
administration. Please see section 24.5 for examples of data elements contained in this data set.
24.4* Please confirm whether the investigators receive or record identifiers from THIS dataset.
Select all that apply:
Direct Identifiers - stored on data record (e.g. name, initials, phone number, SSN, or medical number
stored on data record)
24.5 Upload
Any applicable Data Use or Data Sharing Agreement(DUA/DSA) - unsigned template is
acceptable. Upload is not necessary if this application refers to an Unfunded Agreement (UFA)
in eResearch Proposal Management.
Data dictionary/data collection sheet/list of data variables to be accessed or received by
study team and recorded for analysis. Upload is not necessary if the variables are fully
described in 24.3 or in a separate protocol.
Name Version
UMHS Data Warehouse Data Dictionary Example(0.01) 0.01
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View: 25. HIPAA Covered Components
Section: 25. Protected Health Information/HIPAA
25. HIPAA Covered Components
Completion of this section is required based on the response provided to question 1-1.2.8, 4-1.1, 5-1.3,
7.3, or 7-3.2.
25.1* Select all sources of HIPAA-regulated data used, received, or analyzed in the study:
Entity
Michigan Medicine hybrid covered entity
Examples: Michigan Medicine electronic medical record; Medical School Office of Research
services such as Data Office for Clinical and Translational Research or Central Biorepository;
University Health Service; School of Dentistry Provider Clinics; U-M Group Health Plan
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View: 25-1. Protected Health Information/HIPAA
Section: 25. Protected Health Information/HIPAA
25-1. Protected Health Information/HIPAA
Completion of this section is required based on the responses to questions 4-1.1, 5-1.3, 7.3, or 7-3.2 and
question 25.1.
25-1.1* Identify the PHI to be used.
Select all that apply:
Hospital/doctor's office records, including test results and dental records
Any records relating to condition, the treatment received, and response to the treatment
Billing information
Demographic information
Personal identifiers
If other, please specify:
25-1.2* Explain why the PHI listed above is the minimum necessary to conduct the study.
In order to link the databases, basic PHI is necessary but only for the original database linking. After
the database is extracted, the patient identifiers are destroyed and cannot be recovered.
The only remaining PHI will be date of surgery in order to enable research into perioperative quality
associated with day of week and season of year.
25-1.3* Will HIPAA authorization for access to the PHI be obtained for all or some subjects?
No - HIPAA authorization will not be obtained from any subjects
25-1.3.2* If HIPAA authorization for access to the PHI will NOT be obtained from some or all
subjects/candidates for recruitment, indicate what alternative(s) will be used:
Select all that apply:
Request for full or partial waiver of HIPAA authorization to be approved by U-M IRB or Privacy Board
Limited data set(s)
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View: 25-2. HIPAA Authorization Waiver Request
Section: 25. Protected Health Information/HIPAA
25-2. HIPAA Authorization Waiver Request
Completion of this section is required based on the response provided to question 25-1.3.2
25-2.1* Waiver of HIPAA authorization requested for:
Select all that apply:
Entire project
If other, please specify:
25-2.2* To ensure that this research use of the PHI involves no greater than minimal risk to
privacy, describe the plan to protect patient-subject identifiers from improper use or
disclosure.
- Theoretically, since patient data is being extracted, there exists a non-zero privacy risk. However,
since the data extraction process is automated and the data structures involved separate patient
identifiers from the data being extracted, the likelihood is EXTREMELY rare. Patient identifiers (DOB,
Name, MRN, Insurance account numbers, SSN) are NOT stored or transmitted at any point during the
data extraction or transmittal process.
- To further mitigate this risk, all data extraction processes are automated to eliminate the possibility of
human error. No research personnel are required to 'match' or review identifiers.
- All database work is performed on UMHS-MCIT approved and secured servers that are physically
located in the UMHS computing environment and maintained by MCIT security standards
- No patient identifiers will ever be stored or transported on portable computing devices (laptops, USB
drives, CD, DVD, etc) that can be lost or misplaced
- No patient identifiers will be stored in any research databases
25-2.3* To ensure that this research use of PHI involves no greater than minimal risk to
privacy, describe the plan to destroy patient-subject identifiers at the earliest opportunity
consistent with the research. Indicate at what point in the research the patient-subject
identifiers will be destroyed. If applicable, provide a health, research or legal justification for
retaining the identifiers.
Only the automated processes responsible for creating the database will have access to identifiers. All
identifiers will be destroyed prior to any members of the study team seeing the data. All files are stored
on a password protected, encrypted database, housed on UMHS-MCIT servers.
An internal perioperative clinical information system number for each operations that is completely
unrelated to the patient medical record number or name remains in the data extract. This system
number cannot be used to ascertain any PHI regarding the patient unless the perioperative clinical
system database is accessed by a database specialist. In rare cases, additional info about a patient
may be requested. In that case, a separate IRB application will be submitted to link the internal system
number to the perioperative clinical information system.
25-2.4* To ensure that this research use of the PHI involves no greater than minimal risk to
privacy, provide assurance that this information will not be reused or disclosed to any other
person or entity (i.e., outside the research study team), except as required by law, for
authorized oversight of the research study, or for other research for which the IRB has granted
a waiver of the HIPAA authorization.
No patient identifier information will be disclosed. Only date of surgery will be used.
25-2.5* Why could this research not practicably be conducted unless the waiver of HIPAA
authorization is granted [45 CFR 164.512 (i)(2)(ii)(B)]?
This research could not be carried out because access to the patient identifier during database
creation is necessary. Please see section on informed consent waiver for further details.
25-2.6* Why could this research not practicably be conducted without access to and use of the
PHI [45 CFR 164.512(i)(2)(ii)(C)]?
This research could not be carried out because access to the patient identifier during database
creation is necessary. Please see section on informed consent waiver for further details.
25-2.7* Will data containing PHI be shared outside of the U-M covered component? (If yes
review the guidelines from UM HIPAA office)
Yes No
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View: 33-1. Children - Secondary Analysis-Only Studies
Section: 33. Children
33-1. Children - Secondary Analysis-Only Studies
Completion of this section is required based on the response provided to question 1-1.2.7 or questions in
Section 6 and 9-1.1.
33-1.1* Permitted Categories of Research: The federal policy and regulations governing
human subject protections specify that research involving children must fall into one of the
following permitted categories. Check all categories of permitted research that apply to this
study. The information provided here must be consistent with the information provided in
Section 6.
Regulatory Category Criteria
The research does not involve greater than minimal risk [45 CFR 46.404].
33-1.1.1* Provide a justification for how the study complies with the selected requirement.
It is a retrospective electronic data review and involves no patient interaction or intervention.
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View: 44. Additional Supporting Documents
Section: 44 Additional Supporting Documents
44. Additional Supporting Documents
44.1 Please upload any additional supporting documents related to your study that have not
already been uploaded. Examples include, but are not limited to, data collection sheets,
newsletters, subject brochures, and instructional brochures.
Name Version
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44.2 Enter any information that should show in a “Supporting Documents” list on the current
submission’s approval notice, such as document names and version numbers or version
dates. Text entered here will AUTOMATICALLY appear word-for-word on the approval letter.
