HomeMy WebLinkAboutC-6068 - Data Use Agreementro
a
t DATA USE AGREEMENT BETWEEN CITY OF NEWPORT BEACH AND THE
U REGENTS OF THE UNIVERSITY OF CALIFORNIA ON BEHALF OF UNIVERSITY OF
CALIFORNIA IRVINE HEALTHCARE
This Data Use Agreement (the "Agreement ") is entered into by the City of Newport
Beach, a California municipal corporation and charter city ( "Covered Entity") and
between The Regents of the University of California, on behalf of its Irvine campus
( "Data User") (collectively the "Parties "), and shall be effective as of .July 15, 2014 (the
"Agreement Effective Date "),
Definitions. The parties agree that the following terms, when used in this
Agreement, shall have the following meanings, and that the terms set forth below
shall be deemed to be modified to reflect any changes made hereafter to such terms
by law or regulation.
a. "HIPAA" means the Health Insurance Portability and Accountability Act of 1996,
Public Law 104 -191.
b. "HIPAA Regulations" means the regulations promulgated under HIPAA by the
United States Department of Health and Human Services, including, but not
limited to, 45 C.F.R. Part 160 and 45 C.F.R. Part 164,
c. "Covered Entity" means a health plan, a health care clearinghouse, or a health
care provider (each as defined by HIPAA and the HIPAA Regulations) who
transmits any health information in electronic form in connection with a
transaction covered by the HIPAA Regulations.
d. "Protected Health Information" or "PHP means Individually Identifiable Health
Information, except that Protected Health Information excludes Individually
Identifiable Health Information in education records covered by the Family
Educational Right and Privacy Act, as amended, 20 U.S.C. § 1232g, records
described at 20 U.S.C. § 1232g(a)(4)(B)(iv), and employment records held by a
covered entity in its role as employer.
2. Obligations of Covered Entity.
a. Limited Data Set. Covered Entity agrees to share the following Protected Health
Information ( "PHI ") with Data User:
• Date of service
• Time of alarm /dispatch
• Incident Number
• Disoatch level
• Paramedic performing assessment
• Primary Impression(s)
• Mechanism of Iniury
• Cause of Iniury
Data Use Agreement
• Initial vital signs
• Age
• Gender
• Ethnicitv
• Race
• Primary language
• Exclusion Criteria as collected in the OCMEDS ePCR
• Patient Disposition (e.g. Transferred AMA Treated & Released etc)
• Level of Transport (ALS or BLS), if applicable
• Emergency Receiving Center (Emergency Department) to which the
patient was transported, if applicable
• Insurance type (Private, Medicaid, Medicare Uninsured, Other,
Unknown
• Time of arrival on scene
• Time beginning transport
• Time of arrival to Emergency Receiving Center
• Time of transfer of care to ED personnel
• Time back in service
• Time Interval: arrival on scene to transport begins
• Time Interval: Transport
• Time Interval: arrival at ED to transfer of care to ED personnel
• Time Interval: arrival on scene until back in service
• Miles driven from scene to ED
• Charges assessed for transport
• Charaes assessed for paramedic assessment of patient
• Claims paid for transport and assessment
The aforementioned Protected Health Information that Covered Entity agrees to share
with Data User shall be referred to herein as the "Limited Data Set." Such Limited Data
Set shall not contain any of the following identifiers of the individual who is the subject of
the Protected Health Information, or of relatives, employers or household members of
the individual: names; postal address information, other than town or city, state and zip
code; telephone numbers; fax numbers; electronic mail addresses; social security
numbers; medical record numbers; health plan beneficiary numbers; account numbers;
certificate /license numbers; vehicle identifiers and serial numbers, including license
plate numbers; device identifiers and serial numbers; Web Universal Resource Locators
(URLs); Internet Protocol (IP) address numbers; biometric identifiers, including finger
and voice prints; and full face photographic images and any comparable images.
Data Use Agreement
b. Release of Information Necessary to Create the Limited Data Set. Upon
approval and signature of this agreement and on receipt of a signed
Confidentiality Agreement, Exhibit A below, the Newport Beach Fire Department
shall make available the information necessary to create the Limited Data Set to
Data User.
3. Obligations of Data User.
a. Performance of Activities. Data User may use and disclose the Limited Data Set
received from Covered Entity only in connection with the performance of the
research activities and health care operations described below:
The primary objective of this study is to assist the Newport Beach Fire
Department and Orange County EMS Agency in compiling baseline data for
the future pilot proiect results. The attached Protocol Narrative & IRB application
b. Authorized Individual
use or receipt of the
individuals who need
Section 3.a.:
i. Shira Schlesinger;
ii. Carl Schultz;
iii. Kristi Koenig;
iv. Kenneth Miller;
Recipients of Limited Data Set. Data User shall limit the
Limited Data Set to the following individuals or classes of
the Limited Data Set for the performance of the activities in
v. Craig Anderson; and
vi. Richard Jones.
c. Assurances of Data User's Non - Employee Agents. Data User shall not disclose
the Limited Data Set to any agent or subcontractor of Data User except with the
prior written consent of Covered Entity. Data User shall ensure that any agents,
including subcontractors, to whom it provides the Limited Data Set agree in
writing to be bound by the same restrictions and conditions that apply to Data
User with respect to such Limited Data Set.
Data Use Agreement
d. Nondisclosure Except As Provided In Agreement. Data User shall not use or
further disclose the Limited Data Set except as permitted or required by this
Agreement or as otherwise required by law.
e. Safeguards. Data User shall use appropriate safeguards to prevent use or
disclosure of the Limited Data Set other than as provided by this Agreement.
Reporting. Data User shall report to Covered Entity within twenty -four (24) hours
of Data User becoming aware of any use or disclosure of the Limited Data Set in
violation of this Agreement or applicable law.
Identification and Contacting of Individuals. Data User shall not identify the
information or contact the individuals included in the Limited Data Set.
4. Material Breach, Enforcement and Termination.
a. Term. This Agreement shall be effective as of the Agreement Effective Date, and
shall continue until the Agreement Is terminated by the Parties or in accordance
with the provisions of this Section 4.
b. Covered Entity's Rights of Access and Inspection. From time to time upon
reasonable notice, or upon a reasonable determination by Covered Entity that
Data User has breached this Agreement, Covered Entity may inspect the
facilities, systems, books and records of Data User to monitor compliance with
this Agreement. The fact that Covered Entity inspects, or fails to inspect, or has
the right to inspect, Data User's facilities, systems and procedures does not
relieve Data User of its responsibility to comply with this Agreement, nor does
Covered Entity's (1) failure to detect or (2) detection of, but failure to notify Data
User or require Data User's remediation of, any unsatisfactory practices
constitute acceptance of such practice or a waiver of Covered Entity's
enforcement or termination rights under this Agreement. The parties' respective
rights and obligations under this Section 4.6. shall survive termination of the
Agreement.
c. Termination. Covered Entity may terminate this Agreement:
I. immediately if Data User is named as a defendant in a criminal proceeding for
a violation of HIPAA or the HIPAA Regulations;
ii. immediately if finding or stipulation that Data User has violated any standard
or requirement of HIPAA, the HIPAA Regulations, or any other security or
privacy laws is made in any administrative or civil proceeding in which Data
User has been joined;
iii, immediately if Covered Entity determines that Data User has breached or
violated a material term of this Agreement; or
iv, pursuant to Section 5.b. of this Agreement.
Data Use Agreement
d. Remedies, If Covered Entity determines that Data User has breached or violated
a material term of this Agreement, Covered Entity may, at its option, pursue any
and all of the following remedies:
i. exercise any of its rights of access and inspection under Section 4.b. of this
Agreement;
ii. take any other reasonable steps that Covered Entity, in its sole discretion,
shall deem necessary to cure such breach or end such violation; and/or
iii. terminate this Agreement immediately.
e. Knowledge of Non - Compliance. Any non - compliance by Data User with this
Agreement or with HIPAA or the HIPAA Regulations automatically will be
considered a breach or violation of a material term of this Agreement if Data User
knew or reasonably should have known of such non - compliance and failed to
immediately take reasonable steps to cure the non - compliance.
Reporting to United States Department of Health and Human Services. If
Covered Entity's efforts to cure any breach or end any violation are unsuccessful,
and if termination of this Agreement is not feasible, Covered Entity shall report
Data User's breach or violation to the Secretary of the United States Department
of Health and Human Services, and Data User agrees that it shall not have or
make any claim(s), whether at law, in equity, or under this Agreement, against
Covered Entity with respect to such report(s).
Disposition of Records. Upon termination of this Agreement for any reason,
including, but not limited to Data User's decision to cease use of the Limited Data
Set, Data User agrees to return or destroy all Limited Data Set data, including
copies and derivative versions.
h. Indemnification, Data User shall indemnify, hold harmless and defend Covered
Entity from and against any and all claims, losses, liabilities, costs and other
expenses resulting from, or relating to, the acts or omissions of Data User in
connection with the representations, duties and obligations of Data User under
this Agreement. The parties' respective rights and obligations under this Section
4.f, shall survive termination of the Agreement.
5. Miscellaneous Terms.
Governing Law. This Agreement shall be governed by and construed in
accordance with applicable federal and California laws.
Amendment. Covered Entity and Data User agree that amendment of this
Agreement may be required to ensure that Covered Entity and Data User comply
with changes in state and federal laws and regulations relating to the privacy,
security, and confidentiality of PHI or the Limited Data Set. Covered Entity may
terminate this Agreement upon thirty (30) days written notice in the event that
Data Uge Agreement
Data User does not promptly enter into an amendment that Covered Entity, in its
sole discretion, deems sufficient to ensure that Covered Entity will be able to
comply with such laws and regulations.
c. No Third Party Beneficiaries. Nothing express or implied in this Agreement is
intended or shall be deemed to confer upon any person other than Covered
Entity and Data User, and their respective successors and assigns, any rights,
obligations, remedies or liabilities.
d, Primacy. To the extent that any provisions of this Agreement conflict with the
provisions of any other agreement or understanding between the parties with
respect to use of the Limited Data Set provided hereunder, this Agreement shall
control.
[Remainder of Page Intentionally Blank. Signatures on Following Page.]
Data Use Agreement 6
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed on the dates written below.
APPROVED AS TO FORM:
OFFICE OF T,11-119 CITY ATTORNEY
Date:
By:
A ro C. Warp ot. iullr
CRT Attorney
ATTEST: JO /f
Date: ! U
70 y: &�jYf A
City Clerk
Data Use Agreement
CITY OF NEWPORT BEACH,
A Californi mu c' corporation
Date: /
By:
Chief Scott Poster
Fire Department
REGENTS OF THE UNIVERSITY OF
CALIFORNIA ON BEHALF OF ITS
IRVINE A PUS
Date: a
7
Compliance Officer
EXHIBIT A
CONFIDENTIALITY AGREEMENT
The federal Health Insurance Portability and Accountability Act ( "HIPAA") and its
regulations, the California Confidentiality of Medical Information Act and other federal
and state laws and regulations were established to protect the confidentiality of medical
and personal information, and provide, generally, that patient information may not be
disclosed except as permitted or required by law or unless authorized by the patient.
These medical privacy laws and regulations apply to all members of the UC Irvine
Healthcare workforce including faculty, staff, residents, fellows, medical and other
health sciences students and volunteers.
In certain circumstances, HIPAA allows members of the University's workforce to use
and disclose a limited data set of health information in order to carry out research or
teaching activities without obtaining the patient or subject's authorization. Likewise,
HIPAA allows the workforce member to create that limited data set of health information
using the medical record or other PHI so long as the workforce member signs this
Confidentiality Agreement and agrees to reasonably safeguard all health information
used and disclosed for these purposes.
As a member of the UC Irvine Healthcare workforce, 1 understand that I may be
working with confidential medical and other sensitive or private information. This
information may include, but is not limited to, medical records, personnel
information, ledgers, verbal discussions, and electronic communications
including e-mail.
2. 1 understand and acknowledge that HIPAA requires that I obtain training on the
requirements of HIPAA and UC Irvine Healthcare's policies and procedures
relating to protection of confidential patient information, and I agree to obtain all
required training before I access, use or disclose any confidential patient
information.
3. 1 acknowledge that It is my responsibility to respect the privacy and confidentiality
of patient and other confidential information. I will not access, use or disclose
patient or other confidential information unless I do so in the course and scope of
fulfilling my duties as a member of the UC Irvine Healthcare workforce. I
understand that I am required to immediately report any information about
unauthorized access, use or disclosure of confidential patient information to the
Privacy Officer for the City of Newport Beach Fire Department.
4. 1 understand and acknowledge that, should I breach any provision of this
agreement, I may be subject to civil or criminal liability and disciplinary action
consistent with applicable UC Irvine Healthcare policies and procedures including
those concerning access, use and disclosure of such information and disciplinary
policies.
Data UscAgreemrmt
5. 1 understand that on occasion I may seek access to a limited data set of
information for the purposes of research, creating research or teaching data
bases or conducting teaching activities and may be responsible for creating that
limited data set. These research, teaching and data bases activities may be for
my own purposes or that of another member of the University's workforce. I may
only create a limited data set for research purposes with the approval of the
Institutional Review Board ("IRB "). Healthcare operations may include teaching
activities such as undergraduate medical education or providing continuing
medical education ( "CME ") courses. Another use of limited data sets would be to
convert existing patient data bases into a data base that may be used for
teaching or research purposes in compliance with HIPAA and other laws.
6. A limited data set is created using protected health information and requires that
certain individual identifiers including names, all addresses other than town, city,
and zip code, and all unique identifying numbers have been removed.
7. 1 understand that I may not use or further disclose the limited data set for
purposes other than research or teaching purposes. I will use appropriate
safeguards to prevent use or disclosure of the information other than as provided
for in this agreement. I will report to the Privacy Officer for the City of Newport
Beach Fire Department and the IRB any use or disclosure of the information not
provided for in this agreement. I will not attempt to identify the information or
contact the subjects of the information,
l
atu
Shire A. Schlesinger. Mb. MPH
(Print Nam )
Z 3 Zolr
(bat &)7
Data Use Agreement
EXHIBIT B
PROTOCOL NARRATIVE FOR EXPEDITED OR FULL COMMITTEE RESEARCH
University of California, Irvine
Institutional Review Board
Version: April 2013
IMPORTANT: CAREFULLY READ THE INSTRUCTIONS FOR EACH SECTION
BEFORE COMPLETING THE PROTOCOL NARRATIVE.
WHEN CUTTING AND PASTING FROM ANOTHER APPLICATION OR PROTOCOL,
PLEASE ENSURE THAT THE INFORMATION IS COMPLETE, SUPPLEMENTED
WHERE NECESSARY, PASTED IN A LOGICAL ORDER, AND IS RELEVANT TO
THE SPECIFIC SECTION.
NEED HELP? CONTACT THE HRP STAFF FOR ASSISTANCE.
HS #: 2014 -1288
For IRB Office Use Only
Lead Researcher Name: Shira A. Schlesinger
Study Title: Data Collection of Low - Acuity Patients Evaluated for EMS Transport to an Urgent Care
Clinic rather than to an Emergency Department
NON- TECHNICAL SUMMARY
Provide a non - technical summary of the proposed research project that can be understood by
IRB members with varied research backgrounds, including non - scientists and community
members. The summary should include a brief statement of the purpose of the research and
related theory /data supporting the intent of the study as well as a brief description of the
procedure(s) involving human subjects. This summary should not exceed % page.
This is a limited data set review of low- acuity patients treated and /or transported by Orange
County paramedics in the cities of Huntington Beach, Newport Beach and the fire department
in Fountain Valley, after calling 911 from April 2014 to April 2015. The limited data set review
will take place retroactively, 30 days after the patient has been treated and /or transported. The
primary objective of this study is to compile baseline data for the State - sponsored Alternate
Destinations pilot project. The project will allow paramedics to transport similar patients to
alternate destinations based on pilot protocols.
The baseline data will be used to evaluate safety and accuracy of electronically guided field
protocols for determining patients with low acuity complaints that could be safely managed in
non - hospital settings. Patient volume, resource utilization and costs of pre - hospital care of
patients with potentially low- acuity conditions will be measured. This limited data set review will
be used to collect baseline data in preparation for implementation of a California EMS
Authority - approved Community Para medicine Alternate Destinations Pilot Project; and to
provide preliminary safety evaluation of field protocols developed for Community Paramedics
use during the Alternate Destinations Pilot Project, without altering patient care in this baseline
period.
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SECTION 1: PURPOSE AND BACKGROUND OF THE RESEARCH
1. Describe the purpose of the research project and state the overall objectives, specific
aims, hypotheses (or research question) and scientific or scholarly rationale for performing
the study.
2. Provide the relevant background information on the aims /hypotheses (or research
question) to be tested and the procedures/products /techniques under investigation.
3. Include a description of the primary outcome variable(s), secondary outcome variables,
and predictors and /or corn parison groups as appropriate for the stated study objectives.
4. Include a critical evaluation of existing knowledge, and specifically identify the information
gaps that the project intends to address.
5. Describe previous research with animals and /or humans that provides a basis for the
proposed research. Include references /citations, as applicable.
This section should not exceed 4 pages.
It is estimated that 20% of patients calling 911 have medical problems that could be treated at a
facility other than an Emergency Department (ED). Each transport to an ED following 911 -
activation may result in charges of up to $2000 for ambulance response and transport and
thousands of dollars for an ED visit. Transport to alternate destinations could result in significant
cost savings to patients. Currently, California statutes require all patients cared for by EMS
responders be transported to an ED. The patient must either agree to ambulance transport to an
ED, or sign out Against Medical Advice (AMA), with the associated stigma/guilt of this decision. In
addition, the transport of patients to an ED with minor injuries that could otherwise be managed in
non - emergent settings may delay care for more critical ED patients. This Is especially the case
when these patients arrive by ambulance and are thus prioritized over walk -in patients for
nursing /physician evaluation, and particularly in EDs receiving significant numbers of ambulance
arrivals for non - emergent presentations.
With the focus on quality of care and decreasing medical expenditures, there has been resurgent
interest in decreasing ED visits, and in triaging patients to the most appropriate source of care,
regardless of the method of transport. Thus, the State of California EMS Authority (EMSA) is
currently planning pilot projects to evaluate possible changes to the Paramedic Scope of Practice
in California that would allow paramedics to provide increased assessment to patients in the field,
and to make disposition decisions on patients with the intent of transporting low acuity patients to
alternate destinations, rather than to EDs. Although multiple estimates exist, it is unclear how
many visits are potentially unnecessary, and what the actual costs to the patient and system are
from these potentially unnecessary visits. Nor is it clear whether field presentation can be used to
appropriately triage patients as requiring either emergent or urgent care.
Study Hypotheses
The central aim of this study is to compile baseline data on the pilot project which contends that
patients who call 911 with medical complaints expected to result in low- acuity diagnoses can
be assessed in the field as requiring emergent vs. urgent care, based on standardized
protocols and the limited information available to paramedics. The study design is a limited
data set review of all patients with specified low- acuity complaints who contact 911 during the
research project period.
Low- acuity patients occupy a significant time resource both during field response and
in ED patient hours.
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The primary study endpoint will be a descriptive analysis of patient volume that may be eligible
for Alternate Destination transport during the forthcoming EMSA- endorsed Community
Paramedicine Pilot Project, and to create baseline statistics for comparison and analysis of
changes during the pilot period. Total number of applicable patients, on- scene, transport time
and tum- around time for field response will be retroactively evaluated for patients in the study
group. In addition, hospital outcomes data including ED length of stay, as well as hospital
length of stay for admitted patients, will be considered, to provide preliminary estimates of
number of patient care hours that are provided by EMS and hospital personnel to these
patients.
Huntington Beach, Newport Beach, and Fountain Valley Fire Departments use OCEMS as a
repository for their electronic files. Data use agreements with the three fire departments will
allow OCEMS to provide UCI with all data gathered by the fire departments for patients over 18
that meet the recruitment criteria. OCEMS collects data from hospitals as part of the Paramedic
Receiving Facility certification. OCEMS will provide UCI with a limited data set with the only
Identifiable information being the incident code, dates of treatment and the patient zip code
Transport of low- acuity patients to EDs results in real costs of care and charges to
patients and payors.
Costs of transport and treatment for eligible and consented patients will be collected from EMS
provider Quality Improvement (QI) data.
Cost of transport will be defined as unit hour cost of response as defined by the EMSA as: [(Crew
wages & benefits + fleet cost) X time period of shift, e.g. 24 hrs)] / # eligible transports. Charges
will be collected as the actual billed charges sent to the patient following the episode of care.
Prehospital patient care protocols with specified inclusion and exclusion criteria can be
used to predict which patients would be appropriate for a non - Emergency care setting.
Study endpoint analyzed to test this hypothesis will be the proportion of patients seen by
paramedics after 911 is called during the study period, who met inclusion criteria (based on the
paramedic's record of patient's medical complaint), and did not meet specified exclusion
criteria, and who are discharged from EDs with ICD -9 /ICD -10 codes indicative of low acuity
diagnoses. In retroactive review of prehospital patient care data set, study personnel will
assess the proportion of patients who met inclusion criteria and did not meet exclusion criteria
as assessed by the paramedics, designating those patients as 'alternate destination
appropriate by protocol ". Using this population, hospital disposition data from the limited data
set will be queried to determine ED length of stay, disposition, and ICD -9 /ICD -10 codes
associated with the visit. Inappropriate Alternate Destination patients will be any patients who
were deemed "alternate destination appropriate by protocol" but were also admitted as an
inpatient from their ED visit. Current EMS research for trauma patients proposes an acceptable
under - triage rate of 5 -10 %. A final rate exceeding 5% of patients deemed "alternate destination
appropriate by protocol" who were admitted as an inpatient, transferred to another facility, or
died in the ED will be considered failure of the hypothesis.
SECTION 2: ROLES AND EXPERTISE OF THE STUDY TEAM
List all study team members below.
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1. Identify each member's position (e.g., Associate Professor, graduate or undergraduate
student) and department, and describe his or her qualifications, level of training and
expertise. Include information about relevant licenses /medical privileges, as applicable.
2. Describe each team member's specific role and responsibility on the study.
3. Faculty Sponsors - list as Co-Researchers and describe their role on the project; Include
oversight responsibilities for the research study.
4. Explain who will have access to subject Identifiable data.
5. Indicate who will be involved in recruitment, informed consent process, research
procedureslinterventions, and analysis of data.
Lead Researcher:
Shire A. Schlesinger, MD, MPH
Emergency Medicine
Dr. Schlesinger will be the site Investigator responsible for project development, maintaining
the records database from information provided by OCEMS and the participating Fire
Departments, and developing interim and final reports. Dr. Schlesinger will be involved in data
analysis and have access to patient identifiable information.
Co-Researcher(s):
Carl Schultz, MD
UCI Department of Emergency Medicine
EMS /Disaster Medicine Fellowship Director
Research Director, Center for Disaster Medical Sciences
Dr. Schultz is a Faculty Sponsor of the work and the main supervisor responsible for oversight
of Dr. Schlesinger's progress. Dr. Schultz will provide coordination for administrative linkage
with CDMS and UCI DEM research staff. Dr. Schultz will be involved in data analysis and have
access to patient identifiable information.
Kristi L. Koenig, MD
Director, Center for Disaster Medical Sciences
UCI Department of Emergency Medicine
Dr. Koenig is a Co- investigator of the work. She will provide supervision of Dr. Schlesinger, and
will also provide coordination for administrative linkage with CDMS and UCI DEM research
staff. Dr. Koenig will be involved in data analysis and have access to patient identifiable
information.
Kenneth Miller, MD, PhD
Assistant Medical Director, OCEMS
Dr. Miller will be the OCEMS liaison responsible for providing and verifying patient recordstdata
provided by OCEMS and the OCFCA. Dr. Miller will have access to patient identifiable
information.
Research Personnel:
Craig Anderson, PhD
Dr. Anderson will be responsible for assisting in data analysis for development of interim and
final reports. Dr. Anderson will not have access to patient identifiable information.
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SECTION 3: RESEARCH METHODOLOGY /STUDY PROCEDURES
A. Study Design and Procedures
1. Provide a detailed chronological description of all study acttvlties (e.g., pilot testing,
screening, intervention/interaction /data collection, and follow -up) and procedures.
a. Include an explanation of the study design (e.g., randomized placebo- controlled, cross-
over, cross - sectional, longitudinal, etc.) and, if appropriate, describe stratification,
randomization, and blinding scheme,
b. Provide precise definitions of the study endpoints and criteria for evaluation; if the
primary outcomes are derived from several measurements (i.e., composite variables)
or if endpoints are based on composite variables, describe precisely how the
composite variables are derived.
c. Indicate how much time will be required of the subjects, per visit and in total for the
study.
d. Indicate the setting where each procedure will take place /be administered (e.g. via
telephone, clinic setting, classroom, via email). Note., If any of the procedures will take
place at off - campus locations (e.g., educational institutions, businesses, organizations,
etc.) Letters of Permission are required.
e. If a procedure will be completed more than once (e.g., multiple visits, pre and post
survey), indicate how many times and the time span between administrations.
2. For studies that involve routine (standard of care) medical procedures:
Make clear whether procedures are being done for clinical reasons or for study purposes,
including whether the procedures are being done more often because of the study. Use the
following guidelines to determine the extent to which standard procedures and their
associated risks need to be described in protocol:
a. If the standard procedure is not explicitly required by the study protocol, the protocol
need not describe that procedure or its risks.
b. If the standard procedure is a main focus of the study (e.g., one or more arms of a
randomized study is standard) or is explicitly required by the study protocol, the protocol
must include a full description of the procedure and its risks.]
3. It is strongly recommended that you include a table of visits, tests and procedures. Tables
are easier to understand and may help to shorten long repeated paragraphs throughout the
narrative.
4, if study procedures include collecting photographs, or audio /video recording, specify
whether any subject identifiable information will be collected and describe which identifiers
will be collected, if any.
5. Describe how the subject's privacy will be protected during the research procedures.
Note: This is not the same as confidentiality (see the Privacy and Confidentialify web
page).
6. Be sure to submit data collection instruments for review with your a -I RB Application
(e.g., measures, questionnaires, interview questions, observational tool, etc.).
Study Period: April 15, 2014 — April 31, 2015
Patients with specific conditions that are likely to be of low acuity will be evaluated and
managed in the field by Fire Department paramedics per pilot protocols set up by California
Stat EMSA - sponsored Community Paramedicine Pilot Project. Paramedics will be guided
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through a series of questions in the electronic patient care record that may indicate the
likelihood that the patient required emergency transport to an ED, rather than urgent or
Scheduled outpatient treatment.
Fire department emergency responders create incident numbers for each incident that they
attend, this number will be used to identify patients for data collection. Fire department
Electronic Patient Care Records (ePCR) are stored by OCEMS. OCEMS also collects hospital
information as part of their Paramedic Receiving Facility certification. Congruent with data use
agreements with each fire department, OCEMS will provide UCI researchers with a limited data
set with demographic and primary impression information for the study period which will be
retroactively reviewed, 30 days after care, on a monthly basis to select appropriate subjects.
Based on research study inclusion criteria, UCI will determine which patients would be eligible
for the Alternate Destinations Pilot Project. The selected patient incident numbers will be
provided to OCEMS and the fire departments to gain more detailed Information. The fire
departments will then provide costs and charges for transport for the selected patients and
OCEMS will provide figures on ED length of stay, disposition of the patient from the ED (i.e.
admitted, discharged, eloped, etc.), and ICD -9 /ICD -10 diagnosis codes associated with the
visit. The only identifiable information will be the dates of treatment and the zip code of the
initial patient pick up/treatment location.
General service provision information from the OCEMS system will be reviewed for each month
in the study period to include:
A) Total number of EMS transports in the geographic area under evaluation, stratified by:
• Dispatch level
• EDs to which patients are transported,
• Insurancelpayer type (Private Insurance, Medicaid, Medicare, Uninsured)
B) ED Saturation statistics for the a partner EDs involved in the pilot protocol (Kaiser Irvine,
Hoag Newport Beach, Hoag Irvine, Orange Coast Memorial) (defined as average amount of
time spent on ambulance diversion or otherwise closed to ambulance traffic)
OCEMS will provide UCI researchers with a limited data set for each month of the study period,
ePCRs and Image Trend Hospital Outcomes Data will be retroactively, 30 days after care,
reviewed for adult patients seen by paramedics of Huntington Beach, Newport Beach, and
Fountain Valley Fire Departments who meet the following inclusion criteria:
911 complaint with Primary Impression (initial medical complaint) from the following:
• Isolated closed extremity injury
• Laceration with controlled bleeding
• Soft tissue injury
• Isolated fever andior cough
Patients with these primary impressions during the study period will herein be described as
"Eligible ..
For all patients deemed eligible, OCEMS will provide UCI researchers with a revised limited
data set report with the following data. The following data points will be collected from records
retroactively:
• Primary Impression(s)
• Dispatch level
• Mechanism of Injury responsible for primary impression
• ED to which the patients were transported (or other disposition)
• Insurance type (Private, Medicaid, Medicare, Uninsured, Other, Unknown).
• Age
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• Ethnicity
• Race
• Primary language
• Exclusion Criteria as collected in the OCMEDS ePCR
• Turn - around time for ambulance (from dispatch to time returning to service)
• Time on Scene for ambulance (from arrival at patient to commencement of transport)
• Time in Transport (from Scene to ED)
• Time at ED prior to Transfer of Care
• Mileage driven from Scene to ED
• Level of transport (Advanced vs. Basic ambulance transport)
• Cost of EMS response/transport (calculated based on Tum- around Time)
• Charges billed for EMS responsettransport
• Claims Paid for EMS response/transport
• Length of ED stay
• ED disposition (Discharged, Admitted, Transferred, Left Before Treatment Complete,
Death in ED)
• Length of Inpatient Hospital stay for patients dispositioned to Inpatient Hospital status
from the partner EDs
• ICD -9 /ICD -10 codes from ED and /or Inpatient visit
Primary outcome is the accuracy of electronic field protocols in predicting care needs for patients,
defined as proportion of patients who are assessed by physician reviewers in analysis of each of
the months under study as "Appropriate for Alternate Destination" who are considered by the
analysts to be "under- triaged ". Under - triage will be defined as a patient who met inclusion criteria
per review of the prehospital data fields, but was not assessed as meeting exclusion criteria in
the data fields, and was either admitted to inpatient stay, transferred to another hospital, or died
in the ED.
In accordance with existing accepted guidelines on under - triage for trauma patients (DOT 2006),
under - triage will be considered excessive if it exceeds 5 %.
Secondary outcomes under investigation include:
a) Time out -of- service for available paramedic units responding to low- acuity calls;
b) Cost of EMS response to low- acuity calls; and
c) Charges to patients/payors, and claims paid, for EMS transport calls.
As this data collection is intended to meet the requirements for baseline data collection for the
California Stat EMSA - sponsored Community Paramedicine Pilot Project, it will also include
data as required by the state, All of these elements are detailed above.
The patients transported are not UCI patients and will not be seen at UCI hospital. UCI
Researchers have no interaction with the patients or with the Paramedics performing patient
care activities. The information is collected as a result of regular patient care activities by
Paramedics from the included Fire Departments and stored via OCEMS, and /or is data
received from paramedic receiving hospitals as part of existing Quality Improvement/Quality
Assurance agreements between the OCEMS Agency and hospital EDs credentialed as
paramedic receiving centers. No information is collected for research purposes. Potential
eligible subjects are identified via Primary Impression search of ePCRs performed by OCEMS
staff at the end of each month and sent in a deidentifed list to the UCI research team for further
selection of eligible subjects. This limited data set including all patients meeting Primary
Impression criteria as described above will be shared with the UCI research team by OCEMS
and the included Fire Departments at the end of each calendar month. UCI researchers will
have no contact with patients and are receiving only this limited data set, with no subject
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identifying information. As potentially eligible subjects for the study are not selected until after
patient care activities are completed, and UCI is not aware of the patients' identities, consent
will not be solicited from these transported patients.
B. Statistical Considerations
1. Statistical Analysis Plan: Describe the statistical method(s) for the stated specific aims
and hypotheses described In Section 1. Note: Required for sclentiflc review.
2. Explain how the overall target sample size was determined (Provide power/ sample
size justification for the study).
If a statistical analysis plan Is not appropriate for your study design, please describe a
plan for assessing your study results.
The majority of data, and outcomes, are descriptive in nature. We will use commonly available
statistical software (SPSS or STATA) to calculate means, medians, and ranges /spread where
appropriate.
SECTION 4: SUBJECTS ( PERSONS /CHARTS /RECORDS/SPECIMENS)
A. Number of Subjects (Charts /Records /Biospecimens)
1. Indicate the maximum number of subjects to be recruited /consented on this UCI
protocol. This is the number of potential subjects you may need to recruit to obtain your
target sample size. This number should include projected screen failures and early
withdrawals. Note: The IRB considers individuals who sign the consent form to be
"enrolled" in the research.
2. For Mail/Internet surveys Include the number of people directly solicited.
3. If the study involves use of existing charts, records, biospecimens, specify the maximum
number that will be reviewed /tested to compile the data or the sample population necessary
to address the research question.
Maximum number of subjects is estimated at 10,000 —this indicates the maximum number of
patients estimated to be seen by the 3 participating Fire Departments over the 1 year study
period with the 4low- acuity Primary Impressions under investigation. However, we do not know
how many of these patients will be without exclusion criteria (i.e. will be retroactively deemed
as not requiring emergent transfer to an ED)..
4. Of the maximum number of subjects listed above, indicate the target sample size for the
study. This is the number of subjects expected to complete the study or the number
necessary to address the research question.
5. For socia0ehav /oral research, the maximum sample size is often similar to the target
sample size. If the maximum sample size is significantly greater (i.e., z 1.5x )tan the
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target sample size provide ajustification.
6. For studies where multiple groups of subjects will be evaluated, provide a breakdown per
group (e.g. controls vs. experimental subjects; children vs, adults; by age group).
Target sample size for this study is 300 patients meeting inclusion criteria for whom we are
able to attain outcomes data from receiving EDs.
7. For multi - center research, indicate the overall sample size for the entire study (across all
sites).
[ X I Not applicable - This study is not a multi- center research study.
8. Demonstrate that the target sample size will be sufficient to achieve the study goal and
should coincide with the statistical approach described in Section 3B. Note: Required for
scientific review.
9. Sources and Information of assumed group effects and variability should be supplied (e.g.,
pilot data; data from related literature). Note: Required for scientific review.
Target sample size for this study is 300 patients meeting inclusion criteria for whom we are
able to attain outcomes data from receiving EDs. This will lend an 80% power to a true
proportion of 5% patients inappropriately undertriaged by the electronic protocol guidance.
B. Inclusion and Exclusion Criteria
1. Describe the characteristics and provide justification for inclusion of the proposed
subject population. At a minimum include information about the age and gender of the
study population.
2. Describe different subject groups (e.g., students and teachers; control group and
treatment group(s), children and adults) separately.
As this study is intended to describe the baseline service use and demographics of a sub -
segment of patients calling 911, we expect a study population to encompass all adults 18 and
older, with genders, races and ethnicities reflective of the demographics of the population
served by the Fire Departments of Huntington Beach, Newport Beach and Fountain Valley.
Information regarding patient status as pregnant, incarcerated or developmentally delayed will
not be available unless it is related to the reason for their 911 call. All patients where
information suggests they can be identified as pregnant, incarcerated or developmentally
delayed will be excluded. Study group will include any patients (male and /or female) for whom
EMS primary impression includes one or more of the following:
• Isolated closed extremity injury
• Laceration with controlled bleeding
• Soft tissue injury
• Isolated fever and /or cough
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3. Provide the Inclusion and /or exclusion criteria for the proposed subject population, as
applicable.
[ X ] Not applicable — This is not a clinical investigation and /or the characteristics of the
population sufficiently describe the proposed subject population.
4. If exclusion is based on age, gender, pregnancy /childbearing potential, social /ethnic group,
or language spoken (e.g., Non - English Speakers), provide a scientific rationale.
Pregnant patients, if Identified, will be excluded as the probability of emergent care and /or
observation is higher than the average.
SECTION 5: RECRUITMENT METHODS AND PROCESS
A. Recruitment Methods
Please check all applicable recruitment methods that apply to the study. Place an "X" In the
bracket [ I next to the recruitment method.
[X] This study involves no direct contact with subjects (i.e., use of existing records, charts,
specimens)
• Skip to Section 6.
[ ] UCI IRB approved advertisements, flyers, notices, and /or media will be used to recruit
subjects. Submit advertisements for IRB approval.
• Passive Recruitment - Potential subjects initiate contact with the study team.
• Complete Question 5B -Explain where recruitment materials will be posted.
[ ] The study team will recruit potential subjects who are unknown to them (e.g., convenience
sampling, use of social networks, direct approach in public situations, random digit dialing,
etc.)
• Active Recruitment — Researchers contact potential subjects.
• Complete Question 5B.
[ ] The UCIMC Clinical Trials web page will be used. Submit the UCIMC Standard Research
Recruitment Advertisement for IRB aonroval.
• Passive Recruitment - Potential subjects initiate contact with the study team.
• Skip to Section 6.
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[ The study will be listed on Clinicaltrials.gov. Note., This is required for all clinical trials.
• Passive Recruitment - Potential subjects initiate contact with the study team.
• Skip to Section 6.
[ ] The UCI Social Sciences human subject pool will be used. Submit the Social Science
Human Sublect Pool Recruitment Advertisement for IRS approval.
• Passive Recruitment - Potential subjects initiate contact with the study team.
• Skip to Section 6.
[ ] Study team members will contact potential subjects who have provided permission to be
contacted for participation in future research studies.
• Active Recruitment — Researchers contact potential subjects.
• Complete Question 5B — Explain when and how these Individuals granted
permission for future contact; provide the IRB protocol numbers, if applicable.
[ ] Study team members will approach their own patients, students, employees for
participation in the study.
• Active Recruitment — Researchers contact potential subjects.
• Complete Question 5B.
[ ] Study team members will send UCI IRB approved recruitment materials (e.g., recruitment
flyer, introductory letter) to colleagues asking for referral of eligible participants.*
• Passive Recruitment — Potential subjects initiate contact with the study team or
• Active Recruitment —Colleagues get permission from interested individuals to
release contact information to researchers. Researchers contact potential subjects.
• For Active Recruitment, complete Question 5B.
`Note: Additional requirements for using this recruitment method are included in the Protocol
Narrative instructions.
[ ] Study team members will provide their colleagues with a UCI IRB approved Introductory
letter. The letter will be signed by the treating physician and sent to his/her patients to
inform them about how to contact study team members.
• Passive Recruitment - Potential subjects initiate contact with the study team.
• The IRB approved letter must be sent by the treating physician.
• The study team does not have access to patient names and addresses for mailing.
• Skip to Section 6.
[ ] UCI study team members will screen UCIMC ords to determine subject eligibility and
approach patients directly about study participation.`
• Active Recruitment — Researchers contact potential subjects.
• Complete Appendix T to request a partial waiver of H/PAA Authorization.
• Complete Question 5B.
" Note Additional requirements for using this recruitment method are included in the Protocol
Narrative instructions.
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[ ] Other Methods: <indicate the recruitment method(s) here>
• Complete Question 5B, as applicable.
B. Recruitment Process
1. Based on the methods checked above, describe and provide details of the recruitment
process (i.e. when, where, by whom and how potential subjects will be approached, e.g.
screening medical charts, findings subjects during routine patient visits, etc.).
2. If you will recruit by mail, e-mail, or phone, explain how potential subjects' contact
Information will be obtained.
3. If active recruitment methods will be used (i.e., researchers will make direct contact with
subjects for the purpose of recruitment), explain how the Individual's privacy will be
protected. Note: This is not the same as confidentiality (see the Privacy nd
Confidentialiy web page).
Not Applicable
SECTION 6: INFORMED CONSENT PROCESS
1. Specify how consent will be obtained and describe the specific steps for obtaining
Informed consent.
2. Include information about when and where consent will take place and the length of time
subjects will be given to decide whether they wish to participate.
3. If study team members will approach their own patients, students, or employees for
participation in the study, explain what precautions will be taken to minimize potential
undue influence or coercion, and how compromised objectivity will be avoided.
4. If children are involved in this study, please describe the parental permission process and
the child assent process.
5. Be sure to submit the consentlassent document(s) with your a -IRB Application (i.e. Study
Information Sheet, Recruitment script, Consent Form, etc.).
6. If this study involves the creation, use, or disclosure of Protected Health Information (PHI),
specify the process for obtaining HIPAA Authorization. Be sure to submit the HIPAA
Research Authorization form with your a -IRB Application.
Check all that apply:
( ] Written (signed) informed consent will be obtained from subjects. Signed informed
consent, parental permission, and /or child assent will be obtained from subjects, as
applicable. Describe the informed consent process.
[ ] Requesting a waiver of written (signed) informed consent (i.e., signed consent will not
be obtained). Informed consent, parental permission and /or child assent will be obtained
from subjects, as applicable. Explain how informed consent will be obtained.
Complete Appendix P.
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[ X ] Requesting a waiver of informed consent (I.e., consent will not be obtained). Complete
Appendix O. Skip to Section 7.
7. Non - English Speaking Participants: In order to consent subjects who are unable to read
and speak English, the English version of the consent form must be translated into
appropriate languages once IRB approval is granted.
Check all that apply:
[ ] Not applicable - Only individuals who can read and speak English are eligible for this study.
[ ] The English version of the consent form will be translated into appropriate languages for
non - English speaking subjects once IRB approval is granted. An Interpreter will be
involved in the consenting process. Note: The IRB must officially stamp the translated
consent forms.
[ ] Requesting a short form consent process. Complete Appendix Q.
The short form process will be used for the following languages:
[ ] All non - English languages
[ ]All non - English languages except Spanish
[ ]Other languages (specify): <Type here>
SECTION 7: RISK ASSESSMENT AND POSSIBLE BENEFITS
Note: Review of the instructions for this section is strongly recommended.
A. Risk Assessment
Place an "X" in the bracket [ ] next to the level of review (based upon the investigator's risk
assessment).
[ ] This study involves greater than minimal risk to subjects and requires Full Committee
review.
[ X ] This study involves no more than minimal risk and qualifies as Expedited research.
Provide iustibcation below for the level of review and for the applicable Expedited
Category(les) that you have chosen:
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This study employs a retroactive review of a limited data set, that will be reviewed 30 days after
care, the information will be collected as a result of regular patient care activities, as well as
data received from hospitals as part of existing Quality Improvement /Quality Assurance
agreements between the OCEMS Agency and hospital EDs credentialed as paramedic
receiving centers. UCI will obtain data use agreements from the City of Newport, City of
Hungtington Beach and the Fountain Valley Fire department. IRB approval from OCEMS will
be obtained once UCI IRB approval is granted. No data collection will begin until all approvals
B. Risks and Discomforts
1. Describe the riskstpotential discomforts (e.g., physical, psychological, social, economic)
associated with each intervention or research procedure.
2. Describe the expected frequency (i.e., probability) of a given side effect or harm and its
severity (e.g., mild, moderate, severe).
3. If subjects are restricted from receiving standard therapies during the study, describe the
risks of those restrictions.
4. If collecting identifiable private information, address the risk of a potential breach of
confidentiality.
• There is a risk of potential breach of confidentiality In providing patient information to the
research group. Incident numbers will be used to identify patients and collect data. The
only subject identifiable data provided will be dates of treatment and zip code of initial EMS
pick up /treatment locations.
5. Discuss what steps have been taken and /or will be taken to prevent and minimize any
risks/ potential discomforts to subjects (address physical risks as well as other risks such as
the potential for a breach of confidentiality). Examples include: designing the study to make
use of procedures involving less risk when appropriate; minimizing study procedures by
taking advantage of clinical procedures conducted on the subjects; mitigating risks by
planning special monitoring or conducting supportive inventions for the study.
To prevent risk of breach in confidentiality, patient records will be managed using REDCap
electronic data capture tools hosted at UCI. REDCap (Research Electronic Data Capture) is a
secure, HIPAA - compliantweb -based application designed to support data capture for research
studies, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking
data manipulation and export procedures; 3) automated export procedures for seamless data
downioads to common statistical packages; and 4) procedures for importing data from external
sources. Patient records will be downloaded to an Excel spreadsheet from a secure computer
at OCEMS. The Excel spreadsheet will then be used to upload records to REDCap. Finally, the
Excel spreadsheet will be deleted from the computer.
C. Potential Benefits
1. Discuss the potential benefits that may accrue directly to subjects. Note: Compensation
is not a benefit. Do not include it in this section.
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[ X ] There is no direct benefit anticipated for the subjects.
2. Describe the potential societal /scientific benefit(s) that may be expected from this study.
transport of certain low acuity patients to EDs. This contributes to the EMS and Health Policy
fields by assisting future service and health systems planners in defining the costs and benefits
of providing Alternate Destinations transport options in their communities. In addition, this study
helps to determine the safety of Alternate Destinations protocols prior to their employment in
Paramedic Training and in the forthcoming California state - sponsored Community
Paramedicine pilot project for Alternate Destination transport in Orange County, such that they
may be adjusted as necessary prior to implementation.
D. Risk/Benefit Assessment
Explain why the study risks are reasonable in relation to the potential benefits to subjects and
society.
Minimal risk to patients to contribute to general EMS knowledge and to assuring the safer and
more cost - effective disposition of future patients.
SECTION 8: ALTERNATIVES TO PARTICIPATION
1. Describe the standard or usual care activities at UCI (or study site) that are available to
prospective subjects who do not enroll in this study, as applicable.
2. Describe other appropriate alternative procedures to study participation that are
available to prospective subjects.
3. If no alternatives exist, indicate that the only alternative is non - participation
[ X ] No alternatives exist. The only alternative to subjects is not to participate in the study.
SECTION 9: ADVERSE EVENT REPORTING /MANAGEMENT AND COMPENSATION FOR INJURY
A. Adverse Events and Unanticipated Problems
1. Indicate that you are familiar with UCI's Adverse Events /Unanticipated Problems reporting
policy and procedures. See httr)://www.research.uci.edu/orathrpr)/adverseexpedences.htm
for details.
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[ X ] Although this study involves no Interaction /intervention with research subjects (i.e.,
involves the use of records, charts, blospecimens) an unanticipated problem may still
occur (e.g., a breach in confidentiality), the researchers are aware of UCI's Unanticipated
Problems involving Risk to Participants or Others reporting policy and procedures and will
corn ply with this policy.
[ ] This study involves Interactionlintervention with research subjects. The researchers
are aware of UCI's Unanticipated Problems involving Risk to Participants or Others
reporting policy and procedures and will comply with this policy.
2. If this study involves interaction/intervention with research subjects, explain how the
research team will manage adverse events and unanticipated problems that may occur
during the study or after completion of the study (i.e., provide a plan).
[ X ] Not applicable - This study involves no interactionlintervention with research subjects
(i.e., involves the use of records, charts, and /or biospecimens).
mo;
<Type here>
K Compensation for Injury
For Full Committee protocols, explain how costs of treatment for research related injury will
be covered.
[ X ] Not applicable - This study involves no more than minimum risk and qualifies as
Expedited research.
[ ] Researchers are familiar with and will follow UC policy regarding treatment and
compensation for injury. If subjects are injured as a result of being in the study, UCI will
provide necessary medical treatment. The costs of the treatment may be covered by the
University of California, the study sponsor, or billed to subject or the subject's insurer just
like other medical costs, depending on a number of factors. The University and the study
sponsor do not normally provide any other form of compensation for injury.
[ ] Other: <Type here>
SECTION 10: PARTICIPANT COSTS
1. If subjects or their insurers will be charged for study procedures, identify and describe
those costs.
2. Explain why it is appropriate to charge those cost to the subjects or their insurers.
Provide supporting documentation as applicable (e.g., FDA Device letter supporting
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[ X ] Not applicable - This study involves no interaction /intervention with research subjects (i.e.,
involves the use of records, charts, blospecimens).
[ ] There are no costs to subjects /insurers.
SECTION 11: PARTICIPANT COMPENSATION AND REIMBURSEMENT
1. If subjects will be compensated for their participation, explain the method /terms of payment
(e.g., money; check; extra credit; gift certificate).
2. Describe the schedule and amounts of compensation (e.g., at end of study; after each
session/visit) including the total amount subjects can receive for completing the study.
3. Specify whether subjects will be reimbursed for out -of pocket expenses. If so, describe
any requirements for reimbursement (e.g., receipt).
Note: Compensation should be offered on a prorated basis when the research Involves multiple
sessions.
[ X ] Not applicable - This study involves no interaction /intervention with research subjects (i.e.,
involves the use of records, charts, biospecimens).
[ ] No compensation will be provided to subjects.
[ ] No reimbursement will be provided to subjects.
SECTION 12: CONFIDENTIALITY OF RESEARCH DATA
1. Indicate all identifiers that may be included in the research records for the study. Check all
that apply:
Note: If this information is being derived from a medical record; added to a medical record;
created or collected as part of health care, or used to make health care decisions it qualifies
as PHI under HIPAA. The subject's HIPAA Research Authorization is required Ora waiver of
HIPAA Authorization must be requested (Appendix T).
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[ ] No subject Identifiers are obtained (i.e., researchers will not collect information that can link
the subjects to their data)
OR
[ ] Names [ ] Social Security Numbers [ ] Device identifiers /Serial numbers
[ X ] Dates* [ ] Medical record numbers [ ] Web URLs
[ ] Postal address [ ] Health plan numbers [ ] iP address numbers
[ ] Phone numbers [ ] Account numbers [ ] Biometric identifiers
[ ] Fax numbers [ ] License/Certificate numbers [ ] Facial Photos /Images
[ ] Email address [ ] Vehicle id numbers [ ] Any other unique identifier
[ X ] Other (Specify all): Pick uplTreatment location zip code
' birth date, treatment/hospitalization dates
2. Explain how data will be recorded.
Check all that apply:
[ ] Paper documents/records
[ X ] Electronic records /database
[ ] Audio recording
[ ] Video recording
[ ] Photographs
[ ] Biological specimens
[ ] Other(s) (specify): <Type here>
3. Indicate how data will be stored, secured including paper records, electronic files,
audio/video tapes, biospecimens, etc.
Note: If the research data includes subject identifiable private information and /or Protected'
Health Information, the storage devices or the electronic research files must be encrypted.
Electronic Data (check all that apply):
[ ] Coded data; code key is kept separate from data in secure location.
[ X ] Data includes subject identifiable information. Note: Encryption software is
required. (Provide rationale for maintaining subject identifiable info): Data will include
dates of treatment and zip code of initial treatment/pick up location in order to deduce EMS
travel info, it will be maintained securely on RedCAPS
[ X ] Data will be stored on secure network server.
[ ] Data will be stored on stand alone desktop computer (not connected to
network/intemet)
[ ] Other (specify here):
Hardcopv Data, Recordings and Biospecimens (check all that apply):
[ ] Coded data; code key is kept separate from data in secure location.
[ ] Data includes subject identifiable information (Provide rationale for maintaining subject
Identifiable info):
[ Data will be stored in locked file cabinet or locked room at UCI /UCIMC.
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[ ] Data will be stored locked lab /refrigerator /freezer at UCI /UCIMC.
[ ] Other (specify here):
Data on Portable Devices:
4. Describe the portable device(s) to be used (e.g. laptop, PDA, Pod, portable hard drive
including flash drives).
5. Specify whether subject identifiable data will be stored on the device. If so, justify why it is
necessary to store subject identifiers on the device.
Note; Only the "minimum data necessary "should be stored on portable devices as these
devices are particularly susceptible to loss or theft. ff there is a necessity to use portable devices
for initial collection of identifiable private information, the portable storage devices or the
research files MUST BE ENCRYPTED, and subject Identifiers transferred to a secure system as
soon as possible.
[ X ] Not applicable — No study data will be maintained on portable devices.
Data Access:
6. Specify who, besides the entities listed below, will have access to subject identifiable
private data and records.
7. If there is a code key, specify who on the research team will hold the key, and who will have
access to the key.
8. If publications and /or presentations will include subject identifiable information, specify
where the data will be published and /or presented and address how the study team will
obtain permission from subjects.
Note: Authorized UCI personnel such as the research team and the IRB, the study sponsor (if
applicable), and regulatory entities such as the Food and Drug Administration (FDA) and the
Office of Human Research Protections (OHRP), may have access to study records to protect
subject safety and welfare. Any study data that identifies the subjects should not be voluntarily
released or disclosed without the sutyeots'separate consent, except as specifically required by
law. Publications and/or presentations that result from this study should not Include subject
identifiable information; unless the subject's separate consent has been obtained.
[ ] Not applicable— No subject identifiers will be collected.
[ X ] Not applicable — Only the entities listed above will have access to subject identifiable
private data and records.
Data Retention:
9. Explain how long subject identifiable research data will be retained. The data may
include a code with a separate code key or the data may include subject identifiers.
Notes:
• If more than one of the options below is applicable [e.g., the study involves rhildren],
records should be kept for the longer period.
• Research documentation involving Protected Health Information (PHI) should be retained for
six years e.g., IRB documentation, consent/assent forms — NOT the actual PHI). Investigators
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must destroy PHI at the earliest opportunity, consistent with the conduct of this study, unless
there is an appropriate justification for retaining the identifiers or as required by law.
[ ] Not applicable. No subject identifiable research data will be retained.
[ ] Destroy once data collection is completed
[ X ] Destroy at the earliest opportunity, consistent with the conduct of this research. Specify
timeframe:
Incident codes, treatment dates and zip codes of initial pick up /treatment location, will be
maintained until the records are completed with both pre - hospital and hospital outcomes data.
Once data is complete, all identifiable data will be deleted. De- identified research
documentation will be retained for 3 years following completion of the study period.
[ ] Destroy after publication /presentation
[ ] Maintain for approximately <Type here> years. (e.g., 3 months, etc.)
[ ] Maintain in a repository indefinitely. Other researchers may have access to the data for future
research. Any data shared with other researchers, will not include name or other personal
Identifying information. Note: AppendixMis required.
[ ] Research records will be retained for seven years after all children enrolled in the study
reach the age of majority [age 18 in California] as this study includes children .
[ ] Research records will be retained 25 years after study closure as this study involves in vitro
fertilization studies or research involving pregnant women.
[ ] As this is a FDA regulated study, research records will be retained for two years after an
approved marketing application. If approval is not received, the research records will be kept
for 2 years after the investigation is discontinued and the FDA is notified.
Other: <Type here>
Data Destruction:
10. If audio or video recordings will be taken, specify the timeframe for the transcription
and /or destruction of the audio and video recordings.
11. If photographs will be collected, specify the timeframe destruction of photographs.
[ X ] Not applicable — No audio /video recordings or photographs will be collected.
[ ] Audio or video recordings transcribed; specify time frame: <Type here>
[ ] Audio or video recordings destroyed; specify time frame: <Type here>
[ ] Audio or video recordings maintained indefinitely
[ ] Photographs destroyed; specify time frame: <Type here>
[ ] Photographs maintained indefinitely
Certificate of Confidentiality:
12. Specify whether a Certificate of Confidentiality (COG) has been or will be requested from the
NIH. If yes, explain in what situations personally identifiable information protected by a COG
will be disclosed by the UCI study team.
Note: if the COG has been secured a copy of the COG Approval Letter should accompany the
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!RB application or be provided to the IRB upon receipt.
[ X ] Not applicable — No COC has been requested for this study.
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