GENERAL OWNER CONSENT FORM
“Insert Name of Clinical Trial”
Official Use Only
This protocol has been approved by the [Ryan –VHUP/Widener-NBC] Privately –Owned Animal
Protocol Committee and the University of Pennsylvania Institutional Animal Care and Use
Committee. POAP #
.
As the owner or duly authorized agent for the owner of ___________insert name of pet you are being asked to
have your pet participate in a clinical study to determine “write in a brief statement of the purpose of the
clinical trial.” Before giving your consent to your pet’s participation, please read the following, ask as many
questions as needed to understand what your participation involves, and sign and date the statement at the end
of this document.
PRINCIPAL INVESTIGATOR
List name(s), telephone number(s) and e-mail address(es) of principal investigator(s).
PURPOSE OF STUDY
Consider using one or more of the following sentences:
1. I certify that I am over the age of 18 and hereby grant permission for my pet to participate in a clinical trial
designed to “insert purpose of study.”
2. I have been informed that at this time there is no known therapy (or a known but ineffective therapy) for
“insert disease or medical condition.”
3. The purpose of this trial is to assess the potential benefits, side effects, and/or efficacy of “insert name of
drug or surgical, medical or diagnostic implant or procedure.”
DESCRIPTION OF PROCEDURES
Provide a description of the procedure(s) in layman terms - remember most clients are not doctors.
Consider using one or more of the following sentences.
1. I understand that my pet will be humanely treated at all times and all investigative procedures will be
performed using the customary methods applied to all other client-owned patients at the Ryan Veterinary
Hospital of the University of Pennsylvania (VHUP).
2. I understand that in the course of this study, the investigator(s) may obtain and use blood, urine, and/or
tissue samples, photographs, and x-rays or other diagnostic images of my pet to further their understanding
of the disease or condition and facilitate treatment. I consent to the use of such photographs and diagnostic
images, provided that neither my animal nor I are identified in any publication, reports or presentations
without my written authorization.
3. I understand that I will always have access to important medical information for my pet, but I may not be
able to access certain study-specific information until the completion of the study.
RISKS ASSOCIATED WITH PROCEDURE(S)
Consider using one or more of the following sentences.
1. The known risks and side effects associated with this procedure include “insert information.”
2. I understand that, as with any clinical trial, some currently unknown risks may be identified. It is agreed that
the investigator(s) will inform me of these new risks or any material changes in the way the study will be
conducted.
TREATMENT AND POTENTIAL BENEFITS
Consider using one or more of the following sentences.
1. The potential benefits that my pet shall receive from participating in this study include: “insert potential
benefits.”
2. I understand that there is no guarantee that my pet will benefit from its participation in this study. However,
such participation may provide additional information about the extent of my pet’s disease and, therefore,
influence the course of treatment to help my pet or other animals in the future.
3. I understand that this treatment has a sound medical basis but is the subject of this clinical trial because it
has not been used previously in animals in the same manner as it is being tested in this study.
4. Other than the potential benefits outlined herein, I acknowledge that I will not receive any compensation for
my pet’s participation in this study.
COSTS TO OWNER
Consider using one or more of the following sentences or clauses within a sentence.
1. There is no fee for participating in this study, and VHUP will provide all shelter, food, and veterinary care
for my pet at no charge during the course of the study.
2. I understand that complications may arise during the course of therapy due to the underlying disease and/or
treatments rendered. Nonetheless, I accept financial responsibility for all diagnostic efforts and medical
treatments that might be required as a result of such complications.
3. I shall be responsible for all costs related to complications from the procedure(s) accompanying this study,
treatment of problems unrelated to the study, and therapy required to rescue my pet from complications or
adverse effects related to the study.
4. I have been advised that I am responsible for the initial examination charge and all other diagnostic efforts
or therapeutic products provided for my pet other than those covered by the study.
CONFIDENTIALITY
Consider using the following sentence.
I understand that the written and/or computerized medical records of my pet’s progress while in the study will
be kept confidential. No information by which my pet can be identified will be released or published without
my written authorization.
WITHDRAWING MY PET FROM THE STUDY
I understand that participation in this study is entirely voluntary and that I may withdraw my pet at any time
without prejudicing its present or future care. Refusing to participate will involve no penalty or loss of benefits.
I also understand that my pet may be withdrawn from the study if my veterinarian finds it necessary and/or in
my pet’s best interest. If my pet is withdrawn from the study for any reason, its progress may continue to be
followed and clinical data may continue to be collected from my pet’s medical records without additional
authorization.
OBLIGATIONS OF THE PET OWNER
I understand that post mortem examinations of patients undergoing investigative clinical trials often are
essential to determine the effectiveness of the protocol, evaluate the presence of side effects or complications,
and/or determine a cause of death. Therefore, should my pet die during the course or after the completion of this
study, I agree to notify the primary investigator of such death, give permission for a full post mortem and
histopathological examination of tissue samples to be performed at no charge to me by VHUP personnel, and
agree to bring my pet’s body to the hospital for such an examination. I understand that this requirement can be
waived at the discretion of the investigator as indicated herein (post mortem waived [_____________ signature
of investigator]). In the event a post mortem examination is performed, I wish/do not wish (circle one) to be
notified of the pathologic findings.
My questions about this clinical trial protocol have been answered to my satisfaction. If I have additional
questions regarding this study, I may phone, fax or email the principal investigator at the following numbers
and addresses.
1. Phone
2. Fax
3. E-mail
Additionally, consider adding one of the following sentences.
1. I understand that participation in this study involves a commitment to bring my pet to the Ryan Veterinary
Hospital of the University of Pennsylvania for initial work-up, diagnostic procedures, treatments and (insert
approximate number) follow-up care visits for (insert approximate number) months.
2. I understand that in order to evaluate the effectiveness of the procedure(s) described herein, my pet must be
re-examined on a regular basis. If I fail to return with my pet for the scheduled recheck appointments, my
pet will be removed from the study and all costs originally covered by participation in the study will be
billed to and must be paid by me.
AUTHORIZATION
I have read and understand the foregoing statements and agree to allow my pet to participate in this study. Upon
signing below, I will receive a copy of this consent form.
Case # :
Pet’s Name:
Date:
Client/Owner/Agent’s Printed Name:
Client/Owner/Agent’s Signature:
Clinician’s Signature: