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Patient I.D. Plate
Title:
Version Date:
Principal Investigator:
Application No.:
Informed Consent Template for Cancer Treatment Trials
(English Language)
This is a clinical trial, a type of research study. Your doctor will explain the
clinical trial to you. Clinical trials include only people who choose to participate.
Please take your time to make your decision about participating. You may
discuss your decision with your friends and family. You can also discuss it with
your health care team. If you have any questions, you can ask your doctor for
more explanation.
WHY IS THIS STUDY BEING DONE?
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
WHAT WILL HAPPEN IF I TAKE PART IN THIS RESEARCH STUDY?
HOW LONG WILL I BE IN THE STUDY?
CAN I STOP BEING IN THE STUDY?
Yes. You can decide to stop at any time. Tell the doctor if you are thinking about
stopping or decide to stop. He or she will tell you how to stop safely.
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It is important to tell the doctor if you are thinking about stopping so any risks from the
treatment can be evaluated by your doctor. Another reason to tell your doctor that you
are thinking about stopping is to discuss what follow-up care and testing could be most
helpful for you.
The doctor may stop you from taking part in this study at any time if he/she believes it is
in your best interest; if you do not follow the study rules; or if the study is stopped.
WHAT SIDE EFFECTS OR RISKS CAN I EXPECT FROM BEING IN THE STUDY?
You may have side effects while on the study. Everyone taking part in the study will be
watched carefully for any side effects. However, doctors don’t know all the side effects
that may happen. Side effects may be mild or very serious. Your health care team may
give you medicines to help lessen side effects. Many side effects go away soon after
you stop taking the chemotherapy, although in some cases there are prolonged or even
permanent side effects from stem cell transplantation. In some cases, side effects can
be serious, long lasting, or may never go away. There also is a risk of death from the
treatment.
You should talk to your doctor about any side effects that you have while taking
part in the study.
ARE THERE BENEFITS TO TAKING PART IN THE STUDY?
Taking part in this study may or may not make your health better. While doctors hope
the chemotherapy will be more useful against cancer compared to the usual treatment,
there is no proof of this yet. We do know that the information from this study will help
doctors learn more about chemotherapy as a treatment for cancer. This information
could help future cancer patients.
WHAT OTHER CHOICES DO I HAVE IF I DO NOT TAKE PART IN THIS STUDY?
Your other choices may include:

Getting treatment or care for your cancer without being in a study
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Taking part in another study
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Getting no treatment
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Getting comfort care, also called palliative care. This type of care helps
reduce pain, tiredness, appetite problems and other problems caused by the
cancer. It does not treat the cancer directly, but instead tries to improve how
you feel. Comfort care tries to keep you as active and comfortable as
possible.
Talk to your doctor about your choices before you decide if you will take part in this
study.
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WHAT ARE THE COSTS OF TAKING PART IN THIS STUDY?
For more information on clinical trials and insurance coverage, you can visit the
National Cancer Institute’s Web site at:
http://www.cancer.gov/clinicaltrials/learningabout/payingfor
You can print a copy of the “Clinical Trials and Insurance Coverage” information
from this Web site.
Another way to get the information is to call 1-800-4-CANCER (1-800-422-6237)
and ask them to send you a free copy.
WHAT ARE MY RIGHTS IF I TAKE PART IN THIS STUDY?
Taking part in this study is your choice. You may choose either to take part or not to
take part in the study. If you decide to take part in this study, you may leave the study
at any time. No matter what decision you make, there will be no penalty to you and you
will not lose any of your regular benefits. Leaving the study will not affect your medical
care. You can still get your medical care from our institution.
We will tell you about new information or changes in the study that may affect your
health or your willingness to continue in the study.
HOW WILL YOUR PRIVACY BE PROTECTED?
We have rules to protect information about you. Federal and state laws and the federal
medical Privacy Rule also protect your privacy. By signing this form you provide your
permission, called your “authorization,” for the use and disclosure of information protected
by the Privacy Rule.
The research team working on the study will collect information about you. This includes
things learned from the procedures described in this consent form. They may also collect
other information including your name, address, date of birth, and information from your
medical records. This could include information about HIV and genetic testing, or
treatment for drug or alcohol abuse or mental health problems.
The research team will know your identity and that you are in the research study. Other
people at Johns Hopkins, particularly your doctors, may also see or give out your
information. We make this information available to your doctors for your safety. If you
think this study might affect your clinical care, please inform your doctor.
People outside of Johns Hopkins may need to see or receive your information for this
study.
Examples include government agencies (such as the Food and Drug
Administration), safety monitors, other sites in the study and companies that sponsor the
study.
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Organizations that may look at and/or copy your medical records for research, quality
assurance, and data analysis include:
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National Cancer Institute (NCI) Clinical Trials Cooperative Groups
Representatives of the NCI, Food and Drug Administration (FDA), and
Other U.S. and international governmental regulatory agencies involved in
keeping research safe for people
The Johns Hopkins Medicine IRB
The Central Institutional Review Board (CIRB) of the National Cancer Institute
The Pediatric Central Institutional Review Board (CIRB) of the National
Cancer Institute
We cannot do this study without your authorization to use and give out your information.
You do not have to give us this authorization. If you do not, then you may not join this
study.
We will use and disclose your information only as described in this form and in our Notice
of Privacy Practices; however, people outside Johns Hopkins who receive your
information may not be covered by this promise or by the federal Privacy Rule. We try to
make sure that everyone who needs to see your information keeps it confidential – but
we cannot guarantee that your information will not be re-disclosed.
The use and disclosure of your information has no time limit. You may revoke (cancel)
your permission to use and disclose your information at any time by notifying the Principal
Investigator of this study by phone or in writing. If you contact the Principal Investigator
by phone, you must follow-up with a written request that includes the study number and
your contact information. The Principal Investigator can be reached by phone at Insert
phone number or by sending a letter to:
Include below the name, address, and fax number of the Principal Investigator
If you do cancel your authorization to use and disclose your information, your part in this
study will end and no further information about you will be collected. Your revocation
(cancellation) would not affect information already collected in the study, or information
we disclosed before you wrote to the Principal Investigator to cancel your authorization.
A Certificate of Confidentiality has been obtained for this study from the Department of
Health and Human Services (DHHS).
This Certificate provides that the group conducting this study cannot be forced (for
example, by court subpoena) to disclose information that may identify you in any
federal, state or local civil, criminal, administrative, legislative or other proceeding.
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You should know that a Confidentiality Certificate does not prevent you or a member of
your family from voluntarily releasing information about you or your involvement in this
research. If an insurer or employer learns about your participation and obtains your
consent to receive research information, then we may not use the Certificate of
Confidentiality to withhold this information. This means that you and your family must
also actively protect your privacy.
You should also understand that your doctor and the group conducting this study may
take steps, including reporting to authorities, to prevent you from seriously harming
yourself or others.
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.
WHAT TREATMENT COSTS WILL BE PAID IF YOU ARE INJURED IN THIS STUDY?
Johns Hopkins and the federal government do not have programs to pay you if you are
hurt or have other bad results from being in the study. However, medical care at Johns
Hopkins is open to you as it is to all sick or injured people.

If you have health insurance: The costs for any treatment or hospital care you
receive as the result of a study-related injury will be billed to your health insurer.
Any costs that are not paid for by your health insurer will be billed to you.

If you do not have health insurance: You will be billed for the costs of any
treatment or hospital care you receive as the result of a study-related injury.
By signing this form you will not give up any rights you have to seek compensation for
injury.
WHAT OTHER THINGS SHOULD YOU KNOW ABOUT THIS RESEARCH STUDY?
a. WHAT IS THE INSTITUTIONAL REVIEW BOARD (IRB) AND HOW DOES IT PROTECT YOU?
The Johns Hopkins Medicine IRB is made up of:
 Doctors
 Nurses
 Ethicists
 Non-scientists
 and people from the local community.
The IRB reviews human research studies. It protects the rights and welfare of the
people taking part in those studies. You may contact the IRB if you have questions
about your rights as a participant or if you think you have not been treated fairly. The
IRB office number is 410-955-3008. You may also call this number for other questions,
concerns or complaints about the research.
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If this study may include participants at Howard County General Hospital, include the following:
If you are a participant at Howard County General Hospital, you may contact Jay
Blackman (IRB office at that site) at 410-740-7720.
b. WHAT DO YOU DO IF YOU HAVE QUESTIONS ABOUT THE STUDY?
Call the principal investigator, Dr. _______ at insert telephone number. If you wish,
you may contact the principal investigator by letter or by fax. The address and fax
number are on page one of this consent form. If you cannot reach the principal
investigator or wish to talk to someone else, call the IRB office at 410-955-3008.
If you are taking part at Sibley Memorial Hospital, call Dr.__________at insert
telephone number.
If you are taking part at Suburban Hospital, call Dr. _______________at insert
telephone number.
If you are taking part at All Children’s Hospital, call Dr.____________at insert
telephone number.
c. WHAT SHOULD YOU DO IF YOU ARE INJURED OR ILL AS A RESULT OF BEING IN THIS STUDY?
If you think you are injured or ill because of this study, call Principal Investigator (If the
Principal Investigator is not a medical doctor, include designated physician) at insert
telephone number during regular office hours.
A 24 hour number must be included if the research is more than minimal risk to ensure participant has
access to a physician for an urgent medical problem.
If you have an urgent medical problem related to your taking part in this study,
call designated physician at insert telephone number during regular office hours and
at insert phone or pager number available 24 hours after hours and on weekends.
If you insert a pager number, include the following instructions: After the tone, enter
the phone number where you can be called, press the # key, and hang up.
If you are taking part at Sibley Memorial Hospital and you have a medical problem
related to your taking part in this study, call Dr. ___________at insert telephone
number. If this doctor is not available, the operator will page the “on call physician.”
If you are taking part at Suburban Hospital and you have a medical problem related
to your taking part in this study, call Dr.__________ at insert telephone number. If this
doctor is not available, the operator will page the “on call physician.”
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If you are taking part at All Children’s Hospital and you have a medical problem related
to your taking part in this study, call Dr. __________at insert telephone number. If this
doctor is not available, the operator will page the “on call physician.”
d. WHAT HAPPENS TO DATA AND BIOSPECIMENS THAT ARE COLLECTED IN THE STUDY?
If your study does not include biospecimens, you may delete that word from the heading and text
Johns Hopkins and our research partners work to understand and cure diseases. The
biospecimens and/or data you provide are important to this effort.
If you join this study, you should understand that you will not own your biospecimens
or data, and should researchers use them to create a new product or idea, you will not
benefit financially.
If consent for biospecimens is part of this informed consent, include the following:
With appropriate protections for privacy, Johns Hopkins may share your biospecimens
and information with our research sponsors and partners.
e. WHAT ARE THE ORGANIZATIONS THAT ARE PART OF JOHNS HOPKINS?
Johns Hopkins includes the following:
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The Johns Hopkins University
The Johns Hopkins Hospital
Johns Hopkins Bayview Medical Center
Howard County General Hospital
Johns Hopkins Community Physicians
Suburban Hospital
Sibley Memorial Hospital
All Children’s Hospital
WHERE CAN I GET MORE INFORMATION?
*You may also call the Operations Office of the NCI Central Institutional
Review Board (CIRB) at 888-657-3711 (from the continental US only).
ADD THIS SECTION IF APPLICABLE TO YOUR STUDY
ADDITIONAL STUDIES SECTION
Indicate clearly to participants that this is a separate section
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WHAT DOES YOUR SIGNATURE ON THIS CONSENT FORM MEAN?
Your signature on this form means that:
 you understand the information given to you in this form
 you accept the provisions in the form
 you agree to join the study
You will not give up any legal rights by signing this consent form.
WE WILL GIVE YOU A COPY OF THIS SIGNED AND DATED CONSENT FORM
____________________________________________________________________________________
Signature of Participant
(Print Name)
Date/Time
____________________________________________________________________________________
Signature of Person Obtaining Consent
(Print Name)
Date/Time
ADD ANY OF THE FOLLOWING THAT ARE APPLICABLE FOR THIS STUDY AND DELETE ANY THAT DO NOT APPLY
____________________________________________________________________________________
Signature of Legally Authorized Representative (LAR)
(Print Name)
Date/Time
For ADULTS NOT CAPABLE of GIVING CONSENT (Persons from the following categories in order of
priority may be a Legally Authorized Representative: Health Care Agent; Legal Guardian;
Spouse; Adult child; Parent; Adult sibling; Friend or other relative)
___________________________________________________________________________________________
Relationship of LAR to Participant (indicate why the LAR is authorized
to act as a surrogate health care decision-maker under Maryland Law)
____________________________________________________________________________________
Signature of Parent
(Print Name)
Date/Time
____________________________________________________________________________________
Signature of Legally Authorized Representative (LAR)
(Print Name)
Date/Time
For CHILD PARTICIPANT
____________________________________________________________________________________
Description of LAR’s authority under Maryland Law to act as surrogate health care
decision-maker for child research participant (for example, Legal Guardian, court-ordered representative)
____________________________________________________________________________________
Signature of Parent #2
(Print Name)
Date/Time
(required if DHHS 45 CFR 46.406 or 46.407/FDA 21 CFR 50.53 or 50.54 study)
____________________________________________________________________________
Signature of Child Participant (optional unless IRB required) (Print Name)
Date/Time
____________________________________________________________________________
Signature of Witness to Consent Procedures
(optional unless IRB or Sponsor required)
(Print Name)
Date/Time
NOTE: A COPY OF THE SIGNED, DATED CONSENT FORM MUST BE KEPT BY THE PRINCIPAL INVESTIGATOR; A COPY
MUST BE GIVEN TO THE PARTICIPANTS; IF YOU ARE USING EPIC FOR THIS STUDY A COPY MUST BE FAXED TO 410367-7382; IF YOU ARE NOT USING EPIC A COPY MUST BE PLACED IN THE PARTICIPANT’S MEDICAL RECORD.
ONLY CONSENT FORMS THAT INCLUDE THE JOHNS HOPKINS MEDICINE LOGO CAN BE USED TO OBTAIN THE
CONSENT OF RESEARCH PARTICIPANTS. IF THIS CONSENT FORM DOES NOT HAVE A JOHNS HOPKINS MEDICINE
LOGO, DO NOT USE IT TO OBTAIN THE CONSENT OF RESEARCH PARTICIPANTS.