Clinical trial: NCT02635347
Section: Alternatives
Subsections: What are your alternatives if you don't want to take part in this study?

The alternative is to proceed with the liver transplant without participating in this study.
Clinical trial: NCT02635347
Section: Confidentiality
Subsections: How will information about you be kept private or confidential?|How will information about you be kept private or confidential?|PERMISSION (Authorization) TO USE OR SHARE HEALTH INFORMATION THAT IDENTIFIES YOU FOR A RESEARCH STUDY|What information about me will be used?|Who may use, share or receive my information?|Will I be able to review my research record while the research is ongoing?|How long will my permission last?

All efforts will be made to keep your personal information in your research record confidential,
but total confidentiality cannot be guaranteed. Information collected about you will be in paper
records and in a computer dedicated to research use. The paper records will be stored in locked
file cabinets in locked rooms. Access to computers containing information about you will be
restricted by passwords. Also, those computers will be stored in locked rooms. Only people
connected directly with the study will see or receive information about you.  
3

Title: Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A
Feasibility and Safety Study
PI: Baburao Koneru, MD, MPH  
A description of this clinical trial will be available on ClinicalTrials.gov, as required by U.S. law.
This website will not include information that can identify you. At most, the website will include a
summary of the results. You can search this website at any time.

Information about you and your health is personal and private, so this information generally
cannot be used in research without your written permission. The next few paragraphs tell you
about how researchers want to use and share your health information in this research study.
Your information will only be used as described here or as allowed or required by law. Ask
questions if you do not understand any part of the research or the use of your health
information. If you sign this consent form, you agree to let the researchers use your information
in the research and share it with others as described below.

All information in your medical record except for dental records and financial and billing
information.
Medical information regarding your donor.  
All information in your medical record except for dental records and financial and billing
information.  
Medical information regarding your donor.

The research team may use or share your information collected or created for this study with the
following people and institutions:  
Rutgers University researchers involved in the study;
The Rutgers University Institutional Review Board and Compliance Boards;
The Office for Human Research Protections in the U.S. Dept. of Health and Human
Services.  
Rutgers University researchers involved in the study;  
The Rutgers University Institutional Review Board and Compliance Boards;  
The Office for Human Research Protections in the U.S. Dept. of Health and Human
Services.  
Those persons or organizations that receive your information may not be required by Federal
privacy laws to protect it and may share your information with others without your permission, if
permitted by the laws governing them.

No. We are not able to share information in the research records with you until the study is over.
To ask for this information, please contact the Principal Investigator, the person in charge of this
research study.

Your permission for the use and sharing of your health information will last until the end of the
research study.  
6
Clinical trial: NCT02635347
Section: Duration of Study Involvement
Subsections: How long will the study take and how many subjects will participate?

You will take part in this study for 90 days after your transplant. Once you are discharged, no
extra trips to the hospital are needed for the research. Approximately thirty patients like you will
participate in this study.
Clinical trial: NCT02635347
Section: Participant Responsibilities
Subsections: Who may take part in this study? And who may not?

You are eligible to participate in this study if  
1) You agreed to receive a liver transplant
2) You are either on or about to be put on the waiting list for a liver transplant
3) You are 18 years of age or older
4) You sign a research consent form
5) You may have diabetes, but take only insulin or metformin for sugar control
6) You do not have any serious circulation or nerve problems in your legs  
1) You agreed to receive a liver transplant  
2) You are either on or about to be put on the waiting list for a liver transplant  
3) You are 18 years of age or older  
4) You sign a research consent form  
5) You may have diabetes, but take only insulin or metformin for sugar control  
6) You do not have any serious circulation or nerve problems in your legs  
You are not eligible to participate in this study if you  
1) Have amputations in one or both legs
2) Have diabetes and take certain tablets for sugar control
3) Have circulation and nerve problems in your legs
4) Take nitrate pills for heart or other medical problems
5) Are extremely overweight
6) Are pregnant  
1) Have amputations in one or both legs  
2) Have diabetes and take certain tablets for sugar control  
3) Have circulation and nerve problems in your legs  
4) Take nitrate pills for heart or other medical problems  
5) Are extremely overweight  
6) Are pregnant
Clinical trial: NCT02635347
Section: Participant's Rights
Subsections: Who can you call if you have any questions?|What are your rights if you decide to take part in this research study?|1. Subject consent:|2. Signature of Investigator/Individual Obtaining Consent:|Principal Investigator: Baburao Koneru, MD, MPH|2. Signature of Investigator/Individual Obtaining Consent:|2. Signature of Investigator/Individual Obtaining Consent:

If you have any questions about taking part in this study or if you feel you may have suffered a
research related injury, you can call the study doctor:  
Baburao Koneru, MD, MPH
Department of Surgery
973-972-9599  
If you have any questions about your rights as a research subject, you can call:  
IRB Director, Newark
(973)-972-3608
And  
4

You have the right to ask questions about any part of the study at any time. You should not sign
this form unless you have had a chance to ask questions and have been given answers to all of
your questions.

I have read this entire form, or it has been read to me, and I believe that I understand what has
been discussed. All of my questions about this form or this study have been answered.  
Subject Name:  
Subject Signature:  
Date:

To the best of my ability, I have explained and discussed the full contents of the study
including all of the information contained in this consent form. All questions of the research
subject and those of his/her parent or legally authorized representative have been accurately
answered.  
Investigator/Person Obtaining Consent (printed name):  
Signature:  
Date:

Under certain circumstances, an individual can give consent for another person to take part as a
Subject in this Research Study (hereinafter "Study") because the Subject is unable to consent to
this Study and the Subject has not expressed opposition either to this Study or to the
determination of incapacity. This individual is called the Legally Authorized Representative, or
Surrogate, and is providing Surrogate consent.  
You are being asked to serve as the Surrogate for
, who is
called the Subject in this document. You are being asked to give permission for the Subject to
participate in this Study. Your decision should be based on the Subject's individual health care
instructions and other wishes, if known, or on your best estimation of what you believe are the
Subject's personal values and what the Subject would choose for himself/herself.

To the best of my ability, I have explained and discussed the full contents of the study including all of the
information contained in this consent form. All questions of the research subject and those of his/her parent or
legally authorized representative have been accurately answered.  
Investigator/Person Obtaining Consent (printed name):  
Signature:  
Date:

To the best of my ability, I have explained and discussed the full contents of the study
including all of the information contained in this consent form. All questions of the research
subject have been accurately answered.  
Investigator/Person Obtaining Consent:  
Signature:  
Date:
Clinical trial: NCT02635347
Section: Possible Risks, Discomforts, and Inconveniences
Subsections: Why is this study being done?|What are the risks and/or discomforts you might experience if you take part in this study?|Are there any benefits for you if you choose to take part in this research study?|What will happen if you are injured during this study?

Several complications may happen after a liver transplant operation. Breathing problems may
require you to be on a machine more than a day or two. Kidneys may make less urine than what
is needed. Livers suffer damage when transplanted from one person to another. This damage
could further increase complications after the transplant. The study doctors are interested in  
1

1) When study doctors do CONDITIONING during transplant you will not know and feel
anything. Depending on your medical condition you may be fully awake by the time
study doctors do CONDITIONING after the transplant. If you are awake, you may feel
some discomfort or slight pain in the leg for a minute or two when the rubber cuff is
pumped with air. Also, you will experience some tingling and "pins and needles" for a
minute or two when the air is let out. The goal of this study is to make sure this pain is
not excessive and that CONDITIONING does not interfere with the care you otherwise
receive.  
If you have significant pain from the conditioning, you have the right to opt out of
receiving further conditioning. If you do so, the study doctors will still use information
about you. You may also withdraw your consent for the use of your data, but you must
do this in writing to Baburao Koneru, M.D, MPH, MSB G-599, 185 South Orange
Avenue, Newark NJ 07101.

You may have fewer complications from liver transplantation. If conditioning makes your lungs
work better, you may get off the breathing machine sooner. If conditioning makes your lungs,
kidneys and liver work better, you may leave the ICU and the hospital sooner.  
However, it is possible that you might receive no direct personal benefit from taking part in this
study.

Subjects in this study will be exposed to certain risks of personal injury in addition to those
associated with standard forms of treatment, which include the risks associated with having a
liver transplant. Your regular doctors and nurses have already provided you with that
information in your meetings with them and via the Transplant Handbook.  
In addition, it is possible that during the course of this study, new adverse effects of
CONDITIONING that result in physical injury may be discovered. The University will make
appropriate referrals for medical and/or dental treatment for subjects who sustain personal
injuries or illnesses as a direct consequence of participation in the research. The subject's
health insurance carrier or other third-party payer will be billed for the cost of this treatment;
provided that the University shall not submit to federally funded programs, e.g., Medicare,
Medicaid or CHAMPUS, for reimbursement first if submission to such programs is prohibited by
law. The University will provide no financial compensation. No other type of assistance is
available from the University.
Clinical trial: NCT02635347
Section: Procedures
Subsections: What will you be asked to do if you take part in this research study?

As part of this study, you will receive CONDITIONING treatments a total of 6 times during and
after your liver transplant.  
During your transplant, a rubber cuff will be placed on your thigh. The rubber cuff will be
pumped with air for 5 minutes. Then the air will be let out and left for 5 minutes. This will be
repeated for a total of 3 times. This constitutes one CONDITIONING treatment. The same
treatment will be repeated again at the end of your operation before you leave the operating
room. After the transplant, the same thing will be done once daily in the morning for 4 days.  
2
Clinical trial: NCT02635347
Section: Purpose of Research
Subsections: Principal Investigator: Baburao Koneru, MD, MPH|Who might benefit financially from this research?|Why is this study being done?|Why have you been asked to take part in this study?|What is the purpose of the research and how will my information be used?|3. Signature of Consent Process Witness:|3. Signature of Consent Process Witness:|3. Signature of Consent Process Witness:

This consent form is part of an informed consent process for a research study and it will provide
information that will help you to decide whether you wish to volunteer for this research study. It
will help you to understand what the study is about and what will happen in the course of the
study.  
If you have questions at any time during the research study, you should feel free to ask them
and should expect to be given answers that you completely understand.  
After all of your questions have been answered, if you still wish to take part in the study, you will
be asked to sign this informed consent form.  
You are not giving up any of your legal rights by volunteering for this research study or by
signing this consent form.

Research studies like this one are designed to determine whether a particular treatment is safe
and effective. In certain research studies conducted at Rutgers University, a party or parties
(Rutgers University, the investigatory or a drug company) may gain financial benefits.  
However, in this particular research study, there are no financial benefits to anyone.

Title: Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A
Feasibility and Safety Study  
PI: Baburao Koneru, MD, MPH  
decreasing complications after liver transplants. They are doing research with a simple
treatment called CONDITIONING. This is not a medicine. In CONDITIONING rubber cuffs
(similar to those used to check blood pressure) are put on the thigh. They are filled with air for 5
minutes and then air is let out for another five minutes. This is repeated 3 times.  
Other doctors have found that patients getting this type of CONDITIONING do better after heart
operations. Their kidneys work better. This study's doctors want to make sure CONDITIONING
is safe in patients receiving liver transplants and CONDITIONING does not cause excessive
amounts of pain when done after surgery. Also, this study's doctors want to see if
CONDITIONING would improve your breathing, and make your kidneys and liver work better
after transplant.

You are about to receive a liver transplant. Therefore, we are asking that you consider
participation in this study.

You are being invited to take part in this research study, which is described at the beginning of
this form. The purpose of collecting and using your health information for this study is to help
researchers answer the questions that are being asked in the research.

I have observed the consent process, which included a description of the purposes and
procedures of this Study and an opportunity for questions and answers about this Study. I
attest that I am not the subject, his/her guardian or authorized representative, or a researcher
on this study and can attest that the requirements for informed consent to the medical research
have been satisfied.  
Signature of Witness  
Printed Name of Witness  
Date  
7

I have observed the consent process, which included a description of the purposes and procedures of this Study
and an opportunity for questions and answers about this Study. I attest that I am not the subject, his/her
guardian or authorized representative, or a researcher on this study and can attest that the requirements for
informed consent to the medical research have been satisfied.  
Signature of Witness  
Printed Name of Witness  
Date  
9

I have observed the consent process, which included a description of the purposes and
procedures of this Study and an opportunity for questions and answers about this Study. I
attest that I am not the subject, his/her guardian or authorized representative, or a researcher
on this study and can attest that the requirements for informed consent to the medical research
have been satisfied.  
Signature of Witness  
Printed Name of Witness  
Date  
11
Clinical trial: NCT02635347
Section: Voluntary Participation
Subsections: Will there be any cost to you to take part in this study?|Will you be paid to take part in this study?|What will happen if you do not wish to take part in the study or if you later decide not to stay in the study?|Do I have to give my permission?|Would the person for whom you are signing consent want to take part in this Study?|1. Surrogate Consent:|3. Signature of Consent Process Witness:

Your participation in this study will be free of cost to you. You or your insurance carrier will be
billed for your routine care.

You will not be paid for your participation in this research study.

Participation in this study is voluntary. You may choose not to participate or you may change
your mind at any time.  
If you do not want to enter the study or decide to stop participating, your relationship with the
transplant team will not change, and you may do so without penalty and without loss of benefits
to which you are otherwise entitled.  
You may also withdraw your consent for the use of your data, but you must do this in writing to
Baburao Koneru, M.D, MPH, MSB G-599, 185 South Orange Avenue, Newark NJ 07101. At any
time, the study doctor can take you out of this study because it would not be in your best
interest to stay in it. Your study doctor can stop treatment even if you are willing to stay in the
study.

Title: Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor Livers - A
Feasibility and Safety Study
PI: Baburao Koneru, MD, MPH  
No. You do not have to permit use of your information. But, if you do not give permission, you
cannot take part in this research study. (Saying no does not stop you from getting medical care
or other benefits you are eligible for outside of this study.)

This form tells you about this Study. After reading this entire form and having this Study
explained to you by someone conducting this Study, you can decide if you think the person for
whom you are authorizing consent would want to take part in this Study. It is important to note
that the person for whom you are signing consent does not have to take part in this Study in order
to receive medical care outside this Study.

The purpose and procedures for this Study have been described to me verbally and in writing. My questions
about this Study have been answered and I have been provided with information about who to contact with
additional questions.  
As Surrogate, I freely give my consent to have
take part in this Study and
authorize that his/her health information as described above, be collected/disclosed in this Study. I
understand that by signing this form I am agreeing for the individual named above to take part in research.
I
understand that I will receive a copy of this form to take with me.  
Signature of Surrogate
Printed name of Surrogate
Date

AGREEMENT TO PARTICIPATE  
1. Subject Consent:  
I
have read this entire form, or it has been read to me, and I believe that I understand what has
been discussed. All of my questions about this form or this study have been answered.  
I agree
OR
I do not agree to continue to participate.
(Initial
(Initial)
Subject Name:
Subject Signature:
Date:
Clinical trial: NCT02635347
Section: Withdrawal from Study
Subsections: How will you know if new information is learned that may affect whether you are willing to stay in this research study?|If I say yes now, can I change my mind and take away my permission later?|What will happen if you, as the Surrogate, do not enroll the Subject in this Study, or if the Subject, or you as the Surrogate, later does not want the Subject to participate in this Study?|3. Signature of Consent Process Witness:

During the course of the study, you will be updated about any new information that may affect
whether you are willing to continue taking part in the study. If new information is learned that
may affect you after the study or your follow-up is completed, you will be contacted.

Yes. You may change your mind and not allow the continued use of your information (and to
stop taking part in the study) at any time. If you take away permission, your information will no
longer be used or shared in the study, but we will not be able to take back information that has
already been used or shared with others. If you say yes now but change your mind later for use
of your information in the research, you must write to Baburao Koneru, MD, MPH, Room G-595,
185 South Orange Avenue, Newark, NJ 07101, and tell him of your decision.

The Surrogate can decide not to enroll the Subject. The Subject or the Surrogate can decide
to discontinue at any time the Subject's participation in this Study. Any decision by the
Surrogate not to enroll the Subject or by the Subject or the Surrogate to discontinue the
Subject's participation shall not affect the Subject including the Subject's receipt of medical care
outside the Study. The Subject may withdraw without penalty and without loss of any benefits
to which s/he are entitled.  
Regardless of the Surrogate's consent, the Investigator can take the Subject out of this Study
at any time because it would not be in the Subject's best interest to stay in it.  
8

III. CONSENT TO TAKE PART IN A RESEARCH STUDY FOR INDIVIDUALS
ENROLLED UNDER PRIOR SURROGATE CONSENT  
TITLE OF STUDY: Remote Ischemic Conditioning (RIC) in Recipients of Brain Death Donor
Livers - A Feasibility and Safety Study  
Principal Investigator: Baburao Koneru, MD, MPH  
Under certain circumstances, someone can give consent for another person to take part in a
research study. This person is providing "surrogate consent." The surrogate can make choices
for the subject, if the subject is not able to make choices for him or herself. In fact, since
/
/
,
you have been enrolled in this research study by your surrogate,  
.  
Now that you can make your own decision about whether or not to participate in this research
study, please carefully review this entire form, including both Section I and Section II, which
tells you about the research study. After reading through this form and having the research
explained to you by someone conducting this research, you can decide if you wish to remain in
the study or to withdraw. Your decision to withdraw will not affect the medical treatment you
receive at the University.  
10