eCarePlan Consent Information Sheet - SURVEY

Information Sheet and Authorization
IRB# 25590

TITLE: Implementation of an Electronic Care Plan for People with Multiple Chronic Conditions (eCarePlan
v2)
PRINCIPAL INVESTIGATOR:

David Dorr, MD, MS

(503) 418-2387

CO-INVESTIGATORS:

Anthony Cheng, MD
Emily Morgan, MD

(503) 494-8573
(503) 494-8562

WHO IS PAYING FOR THE STUDY?: Department of Health and Human Services Agency for Healthcare
Research and Quality (AHRQ)
WHY IS THIS STUDY BEING DONE?
You have been invited to be in this research study because you have multiple chronic health conditions.
The purpose of this study is to support the development and testing of a care planner application that is
designed to support care coordination, communication, and collaboration for care team members
across all settings, including the home.
We are asking you to allow us to place a copy of some elements of your personal health information in a
research data store that exists outside the official electronic health record. This copy of your personal
health information will be stored for the duration of the study will not be used and/or shared for future
research, and will be destroyed after the study is complete.
WHAT PROCEDURES ARE INVOLVED IN THIS STUDY?:
You will be given access to a new medical software application that will store your health information,
and present it to you for review. We will ask you to fill out a web-based survey where you will review
the application and answer basic questions about the accuracy of your health information, as well as the
functionality and usefulness of the application.
The health information to be obtained and stored will include diagnoses, procedures, prescription
medications, care providers, and personal health goals. The stored information will not be shared with
anyone outside of the research team. It will not be analyzed for anything other than your perception of
its completeness and accuracy.
If you have any questions, concerns, or complaints regarding this study now or in the future, or you
think you may have been injured or harmed by the study, contact the research team at the following
email address: [email protected]
WHAT RISKS CAN I EXPECT FROM TAKING PART IN THIS STUDY?
Although we have made every effort to protect your identity, there is a minimal risk of loss of
confidentiality.

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WHAT ARE THE BENEFITS OF TAKING PART IN THIS STUDY?
You will not directly benefit from being in this study. However, by serving as a subject, you may help us
learn how to benefit patients in the future.
WHAT ARE THE ALTERNATIVES TO TAKING PART IN THIS STUDY?
You may freely choose not to participate in this study.
WILL I RECEIVE RESULTS FROM THIS STUDY?
You will not receive results from this study.
If you are interested in staying informed about the progress being made on the development of the
application, and continuing to contribute to the development process, we may ask for your permission
to contact you again in the future.
WHO WILL SEE MY PERSONAL INFORMATION?
In this study, we will take steps to keep your personal information confidential, but we cannot
guarantee total privacy. We will do our best to keep your information confidential by following standard
security protocols. The physical systems that host the research data store are managed by OHSU’s
Advanced Computing Center (ACC) in their restricted facility. This means, it is only accessible from within
OHSU’s network by specific individuals. In addition, the research data store shall reside on an entirely
separate server, which is not accessible from the Internet at all.
We may have to release this information to others for example, if the study is audited. However, we
would try to do so without information that could identify you. This release could be to the Institutional
Review Board (ethics review committee) at OHSU, the funder of the study, or the Office of Human
Research Protection (agencies that oversee research). If your information goes outside of OHSU, it might
not be protected under federal law from being used or further shared.
If you decide at any point that you no longer want to participate, and you would like your personal
health information removed from the research data store, you can request this by contacting:
Gina DeNoble, MS
Research Project Coordinator
Department of Medical Informatics and Clinical Epidemiology
Oregon Health & Sciences University
[email protected]
Your request will be effective as of the date we receive it. However, health information collected before
your request is received may continue to be used and disclosed to the extent that it already has been
based on your authorization.
You do not have to allow the use and disclosure of your health information in the study, but if you do
not, you cannot be in the study. If you choose not to participate, or if you decide to stop at any time, it
will not affect your ability to receive health care at OHSU or insurance coverage.

WILL ANY OF MY INFORMATION FROM THIS STUDY BE USED FOR COMMERCIAL PROFIT?
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Information, including any photographs, videotapes, or audiotapes, about you or obtained from you in
this research may be used for commercial purposes, such as making a discovery that could, in the future,
be patented or licensed to a company, which could result in a possible financial benefit to that company,
OHSU, and its researchers. There are no plans to pay you if this happens. You will not have any property
rights or ownership or financial interest in or arising from products or data that may result from your
participation in this study. Further, you will have no responsibility or liability for any use that may be
made of your samples or information.
WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY?:
It will not cost you anything to participate in this study. You will receive $25 for participating, it will be
delivered as a prepaid debit card. You will need to provide your social security number in order to receive
the compensation card.
WHERE CAN I GET MORE INFORMATION?:
This research is being overseen by an Institutional Review Board (“IRB”). You may talk to the IRB at (503)
494-7887 or [email protected] if:
• Your questions, concerns, or complaints are not being answered by the research team
• You want to talk to someone besides the research team
• You have questions about your rights as a research subject
• You want to get more information or provide input about this research
You may also submit a report to the OHSU Integrity Hotline online at
https://secure.ethicspoint.com/domain/media/en/gui/18915/index.html or by calling toll-free (877)
733-8313 (anonymous and available 24 hours a day, 7 days a week).
DO I HAVE TO TAKE PART IN THIS STUDY?
You do not have to join this or any research study. If you do join, and later change your mind, you may
quit at any time. If you refuse to join, or you withdraw early from the study, there will be no penalty or
loss of any benefits to which you are otherwise entitled.
WHAT IF I AM AN OHSU EMPLOYEE OR STUDENT?
The participation of OHSU students or employees in OHSU research is completely voluntary and you are
free to choose not to serve as a research subject in this protocol for any reason. If you do elect to
participate in this study, you may withdraw from the study at any time without affecting your
relationship with OHSU, the investigator, the investigator’s department, or your grade in any course. If
you would like to report a concern with regard to participation of OHSU students or employees in OHSU
research, please call the OHSU Integrity Hotline at 1-877-733-8313 (toll free and anonymous).
HOW DO I TELL YOU IF I WANT TO TAKE PART IN THIS STUDY?
All participants will be asked to follow a secure link that will be sent via email tocomplete the consent
process, asynchronously, using a web-based platform called REDCap. This asynchronous, virtual consent
process will provide all the information listed in this form, and will ask you to indicate your agreement to
participate by clicking ‘YES’ or ‘NO’. Each participant will be able to download a PDF copy of the
information sheet with your ‘YES’ or ‘NO’ indication included.

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