HomeMy WebLinkAboutUniversity of California, Irvine, Consent to Act as a Human U :#. 3r�med Cc,rssn -Juw 20;
UNIVERSITY OF CALIr QRt IA, [R'` iN'_-
CONSENT TO ACT AS A HUMAN RESEARuH SUBJECT
Transport of Low Acuity EMS Patients tC Aliernate Destinations
You are being askeG to par-ficipaie ir F research study. 71arii xv Tor is :onlaletely VolUntarv. a-ase
read the information below and ash questions about anything tna; voL. ac not understand 4. resaarcher
fisted below will be available to answef your questions.
RESEARCH TEAM
Lead Researcher
Shlra A. Schlesinger, MD, MPH —Assistan' --linlcal Professor
Depaamen' o' `mergency Medicine
City Boulevard tNes , Suite `4
Oranae, CA 9286E-3'2L1
(714) 456-_5239 (office)
24 Hour Teiephone Numbe-. (El P, 669-80'�
Other Researchers
Car' Schuh, MD, Kristi L. Koenig, MD, Kennet^ /lille-, Idles, P7_�,
_
Research Personnel
Josh;Hyirik;Ryan Copke, BerketeywNorthrop; t<etaSato,Daae.Marrissey,.Chris.Brown, Karte Johnson,
'Yahya AIwaE�za,.Josaph arrisnh, Jason L6ftii e Steve`li'rtartin,fir-an'Meihnkert,-Jude"Olivas, ;
Joseph:Laser, Joseph..,ariis,.:Ke1lyConte, Rgy Kang,
STUDY LOCATION(S);
Orange County EMS Agency Prehospiml .Ambulances serving the Fire Departments of Newpor Beach,
Huntington Beach, and Fountain !`aliey.
STUDY SPONSOR(S):
Orange County Fire Chiefs .Association
PURPOSE OF THE STUDY
The purpose of this research Study is to assess the safety and effectiveness, of paramedi decision-
making on patieW transport destination, and treatment of 9111 patients it Urgent Care settings. This
program allows specially trained paramedics to determine F certain low risk` patient_, that have called 911.
could be transported to an Urgent Care Center instead of to an emergency department You have beer,
asked to participate in this research study because the paramedic treating you has determined that you
have an injury or illness that could be cared for in an Urgent Care setting. All patients in the study will be
offered a choice of destinations. Cate will be collected from the transporting fire department and
ambulance as weli as the urgen' care o- hospital that you choose. The data will include information about
your trar,spor`time/charges, medical conditions and evaluations, insurance and visit charges. You will
also receive a follow up call in four days for a short survey on your experience.
WHY IS THIS RESEARCH STUDY BEING DONE?
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HOW LONG WILL THE STUDY GO ON?
This study includes transport time tc your chosen destination — either, ar ED or 'Urgent Care Center, and
a follow up call, four days from now that wilt take approximately 5 minutes. Itio other time commitment is
required.
WHAT PROCEDURES ARE INVOLVED WITH THIS STUDY?
Before you can participate in the main part of the study...
You will need to have a "screening" evaluation to aeiermine your ability to consent. The screening
orocess heips the researchers decide if you meet the study repuirements iisted below. The screeninc
procedures include being evaluated ir, the field by ADPT s who have received additional training in
evaluating for potentia! fife or limb-threatening injury. The majority of this evaluation has already been
completed as part of regular ambulance care for 9-11 patients. You will, now be asked to confirm the date;
your location. name, and the rnedicai problem for which you: called 9"' today. lT the ADPT has deemed
you appropriate for transport to Urgent Care you will be offered enroliment in the program and will be
consented for participation.
During the main part of the study...
If the screeninc exams, tests and/or proceduress show that you can continue to be in the study, and you
choose tc take part, then you will have the following procedures and tests done. The main study
procedures include.
Offering you the choice of being transported either to a nearby, saecially approved Urgent Care Center
(UCC; or to the Emergency Department as is standard procedure, Data wil! be collected from the fire
department that tr anspor iec you and from Your destination center/hosoital concerning vour transport time
and cost, medical conditions and evaluations, insurance and cost of visit.
After you complete the main pant of the study...
You will receive a follow up phone call four, days from the day of your transport. You will be asked to
speak with researchers over the phone about your transport and medical care Tor approximateiy
minutes. You will be asked to provide a phone nurnberwhere the researchers can call for This
number wil! not. be USe,C t0" ar'N other pilrpose and will be destroyed after cornpletlOr o- the research.
WHAT ARE THE POSSIBLE SIDE EFFECTS OR RISKS RELATED TO THE STUDY?
If you choose to be transported to an '.Urgent Care Center, you will need tc be accepted by a LICC
orovider on vour arrival via ambulance. If the UCC provider decides at any point that you are not
appropriate Tor UCC care and requests secondary transport to an ED, an ambulance will continue vour
transport to a nearby ED. Given current average transport time of less than 10 minutes in Orange
County, the delay of care is estimated at less than 30 minutes in the case that this should occur. This
would include the trave time to the initia' Urgent Care center, evaluation at that center, and transport
to the nearest Emergency Departmen;.
ARE THERE BENEFITS TO PARTICIPATING IN THIS STUDY?
Participant Benefits
You will not directly benefit from participatior in this study.
If you choose to be transported to an Urgent Care Center(UCC;, it is possible that your stay in the UCC
will be less than would be expected in an Emergency Department.
Benefits to Others or Society
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1-tOW WILL INFORMATION .ABOUT ME AND MY PARTICIPATION BE KEPT?
Scibject Identifiable Data
All identifiable informafior, collected about you, wil be removes at the ens. of data cohection.
Data Stora_ae
esearch data will De siore; eiectronicaliv or: c secure networF: Ire an. encrymed rile will SSWo;"C,
:�roiection. .
Data Retention
The reSearCherS Intend t0 Y 'e the reSear-I- data until anaivsi o ',)= info-oration is complete--.
WHO WILL HAVE ACCESS T O MY STUDY DATA?
The research team, authorized UCi personnel, the study sponsor, and regulatory entities such as the
Food anc Drug Administratior, (FDA) and the Office of Human Research Protections (OHRP), may have
access to your study records to protect your safety and welfare.
Any information derived from this research protect that personaliy i•dentifres you will not be r eieased or
dmclosed by these enfifres without vOU- separate Written consent, except as specifically regUrred 7V la4V,
Research records proviQec is authorized, non-UC' entities wil not contair, identifiable information about
you. Publications and/or presentafion�. resulting from this study will not include ideniifiabie information
about von u.
While the research team will make every effort to keep your personai information confidential., it is
possible that an unauthorized person: might see it. We cannot guarantee total privacy
Investigator Financial' Conflict of Interest
No one on the study 'team has a disciosabie financial interes` related to this research Droiect.
WHO CAN ANSWER MY QUESTIONS ABOUT THE STUDY?
If you have any Comments, concerns, O"pUestion.s regarding the ConGUC of this research, please contact
the research team iisted at the top o`this form.
If von. wish tc ask questions about the study or your rights as a research participant to someone other
than the researchers or if you wish tc voice any suggestions, problems or concerns you may rave about
the study, please contact UC!'s Office of Research by phone, (949) 824-6068 or (949) 824-2125',, by e-
mail at IRBCd)research.-uci.edu or at 5i7' California Avenue, Suite 5G, Irvine, CA 92617.
DISCLAIMER
Patients who cannot consent due to inebriation„ mental incapacity, legal incapacity, or non-
responsiveness will be treated, ih accordance with current regulations and local Drotocols governing
EMT-Paramedics. An exceptior io this requirement will be allowed for study sites where the main
objective is to evaluate alternative destinations for patients with mental health issues that potentially
prevent them from having adequate capacity to consent, and where paramedics participating in the
Behaviors Health Pilot Projec have compieted a specified Psychiatric Emergency Response Team;
Training Course in Behavioral Health issue in addition to the completion of the Community Paramedicine
Core Training. In these cases, efforts shouid still be made to obtain informed consent fo the study, but
inability for psychiatric reasons will not prevent the patient from participating. Patients in these menta
health projects with other reasons for incapacity, such as unresponsiveness, and patients in all other
projects cannot be included in the pilot projects unless consent is iawfully given.
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APPROVED AS—T.Q FORM
f,jj,-jpol City Attortlpy
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iCC)nsent is obtained f-om :he sut)ie-ct via the Sher? -orris aroces as approved by the IRS-
he subiect has decision:-rraI in ca ,ac ty, but cannot read, write, talK or is biind.
h� subiec``s guardianheGaPv aitnxIzed representative 'L AFR' cannot read) write, tali or is oiin,d.
e IRB speci:icativ manila€ed a witness signature for th;s s€udy (e.g., high r:sic andior invasive
research pros=dunes).
Note: 1 he witness must be impartial t;i.e, riot a member of the subjects family. not a member of the study
For the witness:
confirrr, that the information in this consent form was accui ateiv explained to and unaerstood by the
su`Jlect or iegal.fy authorized representative and that informed consent was rmvei': treeiy.
Witness Signature pate
Of no witness sianawre is required, this witness signature sectia-, of the consent form may be feat blani<;.
Printed Name of Witness
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IRB# 8958
University of California Irvine Health
Permission to Use Personal Health Information for Research
Study Title (or IRS Approval Number if study title may breach subject's privacy):
Transport of Low Acuity EMS Patients to Alternate Destinations
Principal Investigator Name. ,
Shira A Schlesinger, MD, MPH
Sponsor/Funding Agency(if funded):
i
Orange County Fire Chiefs Association, California EMS Authority
A. What is the purpose of this form?
State and federal privacy laws protect the use and release of your health information. Under these laws,
the University of California or your health care provider cannot release your health information for research
purposes unless you give your permission. Your information will be released to the research team which
includes the researchers, people hired by the University or the sponsor to do the research and people with
authority to oversee the research. If you decide to give your permission and to participate in the study, you
must sign this form as well as the Consent Form. This form describes the different ways that health care
providers can share your information with the researcher, research team, sponsor and people with
oversight responsibility. The research team will use and protect your information as described in the
attached Consent Form. However, once your health information is released by your health care provider it
may not be protected by the privacy laws and might be shared with others. If you have questions, ask a
member of the research team.
B. What Personal Health Information will be released?
if you give your permission and sign this form, you are allowing,
to release the following medical records containing
your Personal Health Information. Your Personal Health Information includes health information in your
medical records, financial records and other information that can identify you.
❑ Entire Medical Record ❑ Lab & Pathology Reports ® Emergency Department Records
❑Ambulatory Clinic Records ❑ Dental Records ® Financial records
❑ Progress Notes ❑ Operative Reports ❑ Imaging Reports
❑ Other Test Reports ® Discharge Summary ❑ History & Physical Exams
® Other (describe) ❑Consultations ❑Psychological Tests
The specific health information from your medical and financial records include, and are limited to
UC HIPAA Research Authorization 2013
Non-UCi Health Care Provider version
I
® Length of stay,
® Your disposition (discharged, admitted, transferred, etc) from the treating facility
® The diagnoses associated with today's visit
® The charges that were billed for care at today's treating facility, and
® The claims paid by your insurer for treatment at today treating facility.
No additional information will be requested from the records from your visit.
C. Do I have to give my permission for certain specific uses?
Yes. The following information will only be released if you give your specific permission by putting your
initials on the Itne(s).
agree to the release of information pertaining to drug and alcohol abuse, diagnosis or treatment
I agree to the release of HIV/AIDS testing information.
I agree to the release of genetic testing information.
I agree to the release of information pertaining to mental health diagnosis or treatment.
D. Who will disclose and/or receive my Personal Health Information?
Your Personal Health Information may be shared with these people for the following purposes:
1. To the research team for the research described in the attached Consent Form;
2 To others at UC with authority to oversee the research
3. To others who are required by law to review the quality and safety of the research, including U.S
government agencies, such as the Food and Drug Administration or the Office of Human
Research Protections, the research sponsor (California EMS Authority and the Orange County
Fire Chiefs Association) or the sponsor's representatives including but not limited to the Fire
Departments of Fountain Valley, Huntington Beach, and Newport Beach, and the Orange County
EMS Agency, or government agencies in other countries.
E. How will my Personal Health Information be shared for the research?
If you agree to be in this study, the research team may share your Personal Health Information In the
following ways*
1. To perform the research
2 Share it with researchers in the U.S. or other countries,
3 Use it to improve the design of future studies;
4. Share it with business partners of the sponsor, or
5 File applications with U.S. or foreign government agencies to get approval for new drugs or health
care products
F. Am I required to sign this document?
No you are not required to sign this document You will receive the same clinical care if you do not sign
this document However, if you do not sign the document, you will not be able to participate in this
research study.
UC HIPAA Research Authorization 2013 2
Non-UC!Health Care Provider version
G. Optional research activity
If the research I am agreeing to participate in has additional optional research activity such as the
creation of a database, a tissue repository or other activities, as explained to me in the informed consent
process, I understand I can choose to agree to have my information shared for those activities or not.
❑ I agree to allow my information to be disclosed for the additional optional research activities
explained in the informed consent process.
—This section does not apply to this study.
H. Does my permission expire?
This permission to release your Personal Health Information expires when the research ends and all
required study monitoring is over.
I. Can I cancel my permission?
You can cancel your permission at any time. You can do this in two ways. You can write to the researcher
or you can ask someone on the research team to give you a form to fill out to cancel your permission. If
you cancel your permission, you may no longer be in the research study. You may want to ask someone
on the research team if canceling will affect your medical treatment, if you cancel, information that was
already collected and disclosed about you may continue to be used for limited purposes Also, if the law
requires it, the sponsor and government agencies may continue to look at your medical records to review
the quality or safety of the study.
J. Signature
Su_ biect
If you agree to the use and release of your Personal Health Information, please print your name and
sign below. You will be given a signed copy of this form.
Subject's Name (print)--required
Subject's Signature Date
Parent or Legally Authorized Representative
If you agree to the use and release of the above named subject's Personal Health information, please
print your name and sign below
UC H1PAA Research Authorization 2013 3
Non-UCI Health Care Provider version
Parent or Legally Authorized Representative's Name Relationship to the Subject
(print)
Parent or Legally Authorized Representative's Signature Date
Witness
If this form is being read to the subject because s/he cannot read the form, a witness must be present
and is required to print his/her name and sign here:
Witness' Name (print)
Witness' Signature Date
APPROVED r FORM
By
Michael Gates, City Attorney Dlcco`�?,bVS—
UC HIPAA Research Authonzaiion 2013 4
Non-UCI Health Care Provider version