IRB Protocol #:

IRB Approval Date:

INFORMED CONSENT FORM

Please read this consent form carefully before you decide to participate in this study.
Participation in this study is voluntary and you can withdraw from the study at any time
without penalty or loss of benefit. The researcher will answer any questions you have
before you sign this form.

Introduction

Study Title Virtual Reality for Palliative Care Patients

Principal researcher Dr. Laura Farless
Sponsor N/A

Overview

Purpose:
This study will use research to identify if Virtual Reality headsets are helpful in
alleviating pain in Palliative care patients. The purpose of this study is to help
Palliative care patients with pain management. The goals of this study are to help
symptoms of pain without the use of pain medicine.

Procedures:
We’ll ask you to fill out a pain questionnaire before and after the session. You will be
asked to wear a Virtual Reality headset that will show you a setting of your choosing.
This will take place at clinic with other patients present.

Time Commitment:
Each session will last about 15 minutes and can be stopped at any time.

Possible Risks and Benefits

Foreseeable Risks Foreseeable Benefits

Anxiety from the immersive nature of The alleviation of pain without the use of
augmented reality pain medicine
Nausea or dizziness due to motion

Sponsor Protocol Number: Patient Initials _______

1
Date:
 IRB Protocol #:
IRB Approval Date:

St. Joseph’s/Candler I.R.B. Disclaimer

You understand that in the event of physical or psychological injury from this procedure, St.
Joseph’s/Candler Health System, Inc. is not responsible for patient compensation either for lost wages or
for treatment. Therefore, St. Joseph’s/Candler Health System, Inc. does not provide reimbursement for
such injuries. You are not waiving any legal rights, however, nor are you releasing the hospital or physician
from liability for negligence unrelated to the nature and risk of the treatment.

Compensation and Conflict of Interest Clause

Your study doctor will be financially compensated for research related cost not associated with your routine
care. St. Joseph’s/Candler Health System and your study doctor do not, however, have a direct financial
interest with the sponsor or in the final results of the study.  If St. Joseph’s/Candler Health System or your
study doctor has a financial conflict, this will be disclosed to you.

Contact Information

If you have any questions about the research as a study subject, you may contact the study doctor, Dr.
Laura Farless at 912-354-8014, if you have any questions about your rights as a study subject, you may
contact Dr. Jeanne Hungerpiller, Chair of the St. Joseph’s/Candler Health System IRB at 912-819-5290.
Contact IRB chairman, Dr. Harold A. Black at 912-819-8087 for questions and/or in the event of a study
related injury.

Confidentiality Clause

Statement describing how records identifying subjects will be maintained and notice that the St.
Joseph’s/Candler Institutional Review Board (SCJ IRB) and Food & Drug Administration (FDA) may inspect
the records.

Study Information on the Web Clause

A description of this clinical trial will be available on http://www.ClinicalTrials.gov as

required by U.S. Law. This Web site will not include information that can identify you. At
most, the Web site will include a summary of the results. You can search this Web site at any
time.

Sponsor Protocol Number: Patient Initials _______

2
Date:
 IRB Protocol #:
IRB Approval Date:

Signatures

If you have had all your questions answered and would like to participate in this study,
sign on the lines below. Remember, your participation is completely voluntary, and
you’re free to withdraw from the study at any time.

Name of Participant (print)

Signature of Participant Date

If participant is a minor or requires a Legally Authorized Representative:

Name of Parent, Guardian, or Legally Authorized Representative (print)

Signature of Parent, Guardian, or Legally Authorized Representative Date

Sponsor Protocol Number: Patient Initials _______

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Date: