INFORMED CONSENT FORM

Protocol Title:
Sponsor:
Protocol Number:
Study Drug:
Investigator: [Insert Principal Investigator name]

Investigator Telephone: [Insert Principal Investigator telephone number]

INTRODUCTION

WHAT IS THIS STUDY ABOUT AND WHY IS IT BEING DONE?

HOW MANY PEOPLE WILL BE IN THE STUDY AND HOW LONG WILL IT TAKE?

WHAT HAPPENS IF I AGREE TO BE IN THIS STUDY?

PROCEDURES TO ASSESS IF YOU CAN PARTICIPATE IN THE STUDY

STUDY PROCEDURES

WHAT ARE THE RISKS AND SIDE EFFECTS?

WHAT ARE THE POSSIBLE BENEFITS?

WHAT ARE THE COSTS OF BEING IN THE STUDY?

WHAT OTHER CHOICES DO I HAVE?

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WHO IS AUTHORIZED TO COLLECT, USE AND SHARE MY MEDICAL
INFORMATION?

You are being asked to allow the collection of your medical information. You are also being asked
to allow the use and sharing of this information. This is done so that the safety and effectiveness of
the study drug can be studied.

Your medical information is information about your physical and mental health. It includes:
 Your past medical records
 Information about you created or collected during the study. An example is the dates or results
of lab tests
 Information about you that may be related to the study or study drug
 Information that is created or collected outside of the study including:
o physical exams
o surgeries
o other treatment and diagnostic procedures

This information may identify you because it may contain, for example, your:
 name
 address
 telephone number
 date of birth
 social security number
 sex
 ethnicity
 other unique identifiers

If you sign this section, you allow the study staff to collect and use your medical information for the
purpose of this study. You also allow the study doctor to share your medical information with:
 <SPONSOR>. This includes all its affiliates, representatives and contractors
 Other doctors and health care professionals who are involved in the study
 The Institutional Review Board/Ethics Committee (IRB/IEC) that watches over the study and
patients
 Government agencies overseeing this study or the study drug. This includes:
o the [FDA]
o other Department of Health and Human Services agencies
o government agencies in the U.S. and other countries

If you sign this section, you also allow any doctor, hospital, or other medical facility that treats you
after you start the study to disclose any medical information about you. This information may be
related to the study or study drug.. This authorization includes disclosure in the event of your death.

The medical information sent by the study doctor to the study sponsor is called “study data.” Study
data usually do not include your name, address, or social security number. Instead, a code number
and possibly your initials are used. The study data will include your date of birth, sex and ethnicity,
but it is possible that the study sponsor, regulatory authorities, and others may look at all of your
medical information at the study doctor’s site. The reason these persons may look at your medical
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information is to make sure the study has been done properly. Also, they may look to see that the
study data have been collected correctly, or for other reasons allowed by law.

Except as explained in this form, your medical information will be kept confidential. The data and
results from this study may also be shown at meetings or in publications, but in those presentations,
people taking part in the study will not be identified by name.

You have the right to see and copy your medical information related to the study for as long as the
study doctor keeps this information, but you may not be able to see some of your records related to
the study until after the study has been completed. This is because it may affect the quality of the
study.

You may withdraw your authorization (permission) regarding your medical information at any time
by writing to the study doctor at the following address: _______________. If you withdraw this
authorization, you can no longer participate in the study, meaning no new information about you
will be used/added. This will involve no penalty or loss of benefits to which you are otherwise
entitled. If you drop out of the study, the authorization to use or disclose the records for research
will remain until you revoke this authorization. It is up to you if you want to revoke your
authorization. However, the study sponsor may still use information about you that was already
collected and shared with the study sponsor before you withdrew your authorization.

Indicate your agreement to this authorization by checking the box below and signing:

I authorize the use and release of my medical records and health information related to this
study as described above.

Signature of Subject or Legal Representative Date

HOW WILL MY PRIVACY BE PROTECTED?

Every effort will be made to keep the personal information in your research record private and
confidential but absolute confidentiality cannot be guaranteed. Your personal information may be
disclosed if required by law. Your privacy will be respected. You will not be identified by name or
by any other personal identifying information in reports or publications resulting from this study.
Qualified representatives of the following organizations may inspect your medical/study records
and receive information from your medical/study records for quality assurance and data analysis:
 Food and Drug Administration of the U.S. Government or regulatory authority in country where
study is being conducted
 Representatives of <SPONSOR>
 The Institutional Review Board/Ethics Committee who oversees the conduct of this study in
your hospital/clinic

WHAT HAPPENS IF I HAVE A RESEARCH RELATED INJURY?

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All forms of medical diagnosis and treatment, whether routine or experimental, involve some risk of
injury. In spite of all precautions, you might develop medical complications from participating in
this study. If such complications arise, the study staff will assist you in obtaining appropriate
medical treatment. If you experience an illness or injury that is directly caused by your participation
in this study, as a direct result of the study drug being administered in this study, or any test or
procedure you receive as required by this study, care will be provided to you. If a medical
emergency happens, you should get help and tell [insert the name of the Principal Investigator
and/or other involved study doctors] as soon as possible at [insert center and emergency telephone
number]. You will get emergency treatment by your study doctor(s) at this center or at another
medical facility. However, neither [SITE] nor the federal government has a program to pay you if
you experience an illness or injury that is not directly caused by your participation in this study.

If, during the course of the study, you experience any injury as a direct result of the administration
of study medication, the sponsor agrees to pay all medical expenses necessary to treat such injury
(1) to the extent you are not otherwise reimbursed by medical insurance, and (2) provided you have
followed the directions of the study doctor. However, the sponsor will not pay compensation where:
the injury resulted from a medication or procedure outside the study, or the study procedures were
not followed, or if the illness or injury were due to a pre-existing condition, underlying disease, or
to your negligence or willful misconduct.

Please be aware insurance companies may not pay for research related injuries. You should contact
your insurance company for more information.

WILL I BE PAID TO BE IN THE STUDY?

WHO CAN ANSWER QUESTIONS ABOUT THE STUDY AND MY RIGHTS AS A

RESEARCH SUBJECT?

You have the right to ask questions about the study at any time. Please call the study doctor at the
phone number listed on page 1 if:
 You have any questions about this study
 You experience a study-related injury
 You have a medical emergency

If you have any questions about your rights as a research subject or complaints about this study, you
should call [insert IRB/EC name, address and telephone number].

WHAT IF NEW INFORMATION BECOMES AVAILABLE?

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Subject’s Statement of Consent
 I have been told that this is a research study of an investigational drug.
 I have been given sufficient opportunity to consider whether to participate in this study.
 My taking part in this research study is voluntary. I may decide not to take part or to withdraw
from the research study at any time without penalty or loss of benefits or treatment to which I
am entitled.
 If I meet the criteria and would like to take part in this research study, my doctor may enroll me
in the research study.
 The research study may be stopped at any time without my consent either by the study doctor or
by the company sponsoring the research.
 I have been told that my study doctor will be receiving payment from the sponsor to conduct the
research.
 I have had an opportunity to ask my study doctor questions about this research study. My
questions so far have been answered to my satisfaction.
 I have been told how long I may be in the research study.
 I have been told of the procedures and tests that may be performed during the research study.
 I have been told what the possible risks and benefits are from taking part in this research study. I
may not benefit or my condition may worsen if I take part in this research study.
 I do not give up my legal rights by signing this form.
 I have been told that prior to any study related procedures being performed, I will be asked to
voluntarily sign this subject consent and authorization form.
 I authorize access to my medical records by the sponsor, CRO, IRB/EC, or applicable regulatory
agency.
 I have been told that I will receive a signed and dated copy of this subject consent and
authorization form.
 I voluntarily agree to take part in this research study.

_____________________________________________________________________________
Signature of Subject Date

________________________________________
Printed Name of Subject

_____________________________________________________________________________
Signature of Legal Authorized Representative Date

________________________________________
Printed Name of Legal Authorized Representative

_______________________________________
Relationship of Legal Authorized Representative to Subject

I certify that the information provided was given in language that was understandable to the subject.

_____________________________________________________________________________
Signature of Person Obtaining Consent Date

________________________________________
Printed Name of Person Obtaining Consent

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