Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
Protocol Title:
[If required by the sponsor you may add the Sponsor Protocol Number Here:]
[Sponsor Protocol Number: (protocol number)]
DF/HCC Principal Research Doctor / Institution:
DF/HCC Site-Responsible Research Doctor(s) / Institution(s):
[Here identify the specific site and the research doctor responsible at that site.
If there are none, delete this line.]
Consent to Participate in Screening Procedures
If you are a parent or guardian of a child under 18 years old, the word “you” refers
to your child. You, the parent, will be asked to read and sign this document to give
permission for your child to participate. [Delete this paragraph if the study involves
adults only.]
A. INTRODUCTION
The purpose of this screening consent document is to obtain your consent to
undergo certain screening procedures in order to determine whether you are
eligible for participation in a research study at the Dana-Farber/Harvard Cancer
Center.
The screening procedures we will ask you to undergo are not procedures required
for your clinical care. They are procedures (for example, providing blood, tissue,
urine) that are necessary in order to determine whether you meet the requirements
for participation in a research study that might be appropriate to your condition.
The specific procedures will be described on the next page.
When you go to your doctor for treatment, you are considered a patient and your
doctor is customizing treatment to your specific needs. Your doctor will treat you
based upon what is called the “standard of care” or “usual care” for your condition.
This means it is a medically accepted method of treatment. Sometimes individuals
who are at high risk of cancer or have been diagnosed with cancer may be able to
choose from both standard of care options as well as participation in a research
study.
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
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Content Last Revised with OHRS Review:
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Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
Research means that investigators are conducting a systematic investigation
designed to determine whether some specific way of treating a type of cancer is
better than the current standard of care. In some cases, there may be limited or no
accepted standard of care treatments available.
Participation in a research study means that an individual has gone through certain
screening procedures or preliminary tests to determine whether they meet the
requirements to participate in a research protocol that might be appropriate for
their condition.
In order to undergo the screening tests, you must read and sign this consent form
which indicates that you have been told why the screening procedures are being
done and the risks of each procedure.
The decision to participate is yours. You do not have to agree to participate in
screening procedures or any research protocol.
Your care at any of the DF/HCC hospitals will not be impacted if you decide not to
undergo these screening procedures. It would mean, however, that certain
research studies might not be available to you.
If you decide to participate, please sign and date at the end of this form. We will
give you a copy of this form. If you choose not to undergo the screening
procedures, your doctor will discuss with you in more detail other options available
to you.
We encourage you to take some time to think this over, to discuss it with other
people and to ask questions now and at any time in the future.
B. WHY ARE YOU BEING ASKED TO UNDERGO SCREENING PROCEDURES?
[Describe the main study including rationale for why it is being done. Please see
Section B of the Consent Template for Biomedical Research for guidance and
specific language.]
The results of your screening procedures will tell us whether you are eligible for
this study. If you are eligible, the investigator will go over a separate research
informed consent document that relates to that research study in particular. If you
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
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Content Last Revised with OHRS Review:
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Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
are not eligible for this study, you may be able to participate in other research
studies. The investigator will present any other research opportunities to you using
separate informed consent documents.
If you are determined to be eligible, but decide not to participate in the main study
other options may include:


[fill in current standard of care options here in bullet format]
[fill in current standard of care options here in bullet format]
C. WHAT WILL BE DONE WITH THE DATA FROM MY SCREENING TESTS?
[Please explain whether the data be discarded or be kept for future research
pursuant to another protocol. If the data will be retained, the participant must
specifically consent to participate in the research protocol that provides for
retention of the data. ]
D. WHAT OTHER OPTIONS ARE THERE?
Taking part in the screening procedures is voluntary. You may choose to not go
through screening procedures or you may choose to start them and then withdraw
during the procedures.
Please talk to the research doctor about your options before you decide whether
you will undergo the screening procedures.
E. WHAT IS INVOLVED IN THE SCREENING PROCEDURES AND WHAT ARE THE RISKS?
The Required Screening Procedures are the following:
[
] blood draw(s)
Risks: [fill in risks]
[
] bone marrow aspirate(s)
Risks: [fill in risks]
[
] urine collection
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
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Content Last Revised with OHRS Review:
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Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
Risks: [fill in risks]
[
] saliva/cheek swab
Risks: [fill in risks]
[
] tumor specimen
Risks: [fill in risks]
[
] imaging
Risks: [fill in risks]
[
] other procedure (please specify procedure and describe)
Risks:
There are no physical risks to you if archival tumor samples (samples from
previous surgeries or biopsies) are used to analyze your cancer since these
specimens were collected in the past.
There is a small risk that someone may get access to your private health
information from the screening procedures, including the use of archival tissue, but
we try to reduce this risk by putting into place procedures that limit access to your
information.
Your doctor will review with you whether there is enough tissue to have this
screening testing performed. If the doctor finds that there is not enough archived
tissue available, the doctor will discuss this with you and provide guidance
After the screening procedures are completed:
If you are eligible for the research study, you will receive a separate informed
consent form to inform you in detail about the research study itself and all
procedures involved. If you then voluntarily agree to participate in the research
study, you will be asked to sign the separate informed consent form for that study.
F. HOW MUCH TIME WILL THE SCREENING PROCEDURES TAKE?
You will be considered to be participating in the screening procedures phase for as
long as it takes to do the procedures and obtain the results.
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DFCI Protocol Number:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
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Content Last Revised with OHRS Review:
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Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
G. WHAT ARE THE BENEFITS OF THE SCREENING PROCEDURES?
The benefit in participating in the screening procedures is that we can tell whether
you might be eligible to participate in a research study.
H. CAN I STOP PARTICIPATING IN THE SCREENING PROCEDURES AND WHAT ARE MY
RIGHTS?
You have the right to choose not to sign this form. If you decide not to sign this
form, you cannot participate in research studies relating to your condition where
these screening procedures are required.
You can stop participating in the screening procedures at any time.
If you choose not to participate, are not eligible to participate, or change your mind
about doing the screening, this will not affect your present or future care and will
not cause any penalty or loss of benefits to which you are otherwise entitled. If you
choose not to participate and the testing of the tissue has not yet been performed,
the sample will be sent back to the place where it originated. Please be aware that
samples will most likely be tested soon after they are received.
I. WHAT ARE THE COSTS?
There are no costs to you to undergo screening procedures.
If you have questions about your insurance coverage, or the items you might be
required to pay for, please call financial services for information. The contact
information for financial services are
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Beth Israel Deaconess Medical Center: (617) 667-5661
Boston Children’s Hospital: (617) 355-7188
Brigham and Women’s Hospital: (617) 732-5524 or (617) 732-7485
Dana-Farber Cancer Institute: (617) 632-3455
Massachusetts General Hospital: (617) 726-2191
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in clinical
affiliation with South Shore Hospital: (781) 624-4329
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
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Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
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OHRS Version: 07.17.1515
Dana-Farber/New Hampshire Oncology-Hematology: (603) 552-9106
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford
Regional Medical Center: (508) 422-2970
Dana-Farber Cancer Institute at Steward St. Elizabeth’s Medical Center:
(800) 664-3884
Massachusetts General Hospital/North Shore Cancer
Center: (978) 882-6319
Massachusetts General Hospital at Emerson Hospital - Bethke: (978) 2873043 or (978) 287-3064
The Lawrence. & Memorial Cancer Center in affiliation with Dana-Farber
Community Cancer Care: (860) 442-0711 ext. 4702
Cape Cod Healthcare: (508) 862-7575
Lowell General Hospital: (978) 937-6600
Newton Wellesley Hospital: (617) 243-6392
New Hampshire Oncology-Hematology, P.A.: (603) 622-6484
The National Cancer Institute provides an online resource to help people
participating in cancer clinical trials understand which services their insurance
company is required by law to pay. This can be found at the website below or can
be provided by the study team:
www.cancer.gov or 1-800-4-CANCER
J. WHAT HAPPENS IF I AM INJURED OR SICK BECAUSE I TOOK PART IN THESE
SCREENING PROCEDURES?
If you think you have been injured as a result of any screening procedures, tell the
doctor as soon as possible. The doctor’s name and phone number are listed in
this consent form.
[Describe what will be covered in the event of an injury as a result of participation
in the screening tests]
K. WHAT ABOUT CONFIDENTIALITY?
We will take measures to protect the privacy and security of all your personal
information, but we cannot guarantee complete confidentiality of screening data.
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
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Content Last Revised with OHRS Review:
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Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
Medical information created by participating in these screening procedures may
become part of your hospital medical record. Information that does not become
part of your medical record will be stored in your study file.
L. WHOM DO I CONTACT IF I HAVE QUESTIONS ABOUT THE SCREENING
PROCEDURES?
If you have questions about the screening procedures or screening-related injury,
please contact your doctor or study staff as listed below:
For questions about your rights, please contact a representative of the Office for
Human Research Studies at DFCI (617) 632-3029. This can include questions
about your potential participation in a study, concerns about the screening
procedures, a screening- related injury, or if you feel/felt under pressure to agree to
the screening procedures.
M. PRIVACY OF PROTECTED HEALTH INFORMATION
Federal law requires Dana-Farber/Harvard Cancer Center (DF/HCC) and its
affiliated research doctors, health care providers, and physician network to protect
the privacy of information that identifies you and relates to your past, present, and
future physical and mental health conditions (“protected health information”). If you
participate in these screening procedures and sign this consent form you are
allowing, your “protected health information” to be used and shared with others as
explained below.
1. What protected health information about me will be used or shared with
others during this screening procedure?


Existing medical records
New health information created from the screening procedure results
2. Why will protected information about me be used or shared with others?
The main reasons include the following:
 To conduct and oversee the procedures described earlier in this form;
 To ensure the screening procedures meets legal, institutional, and
accreditation requirements;
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
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Content Last Revised with OHRS Review:
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Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
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OHRS Version: 07.17.1515
To conduct public health activities (including reporting of adverse events or
situations where you or others may be at risk of harm); and
Other reasons may include for treatment, payment, or health care
operations. For example, some medical information produced by the
screening become part of your hospital medical record because the
information may be necessary for your medical care. (You will also be given
a notice for use and sharing of protected health information.)
3. Who will use or share protected health information about me?

DF/HCC and its affiliated research doctors and entities participating in the
screening procedures will use and share your protected health information.
In addition, other DF/HCC offices that deal with research oversight, billing or
quality assurance will be able to use and share your protected health
information.
4. With whom outside of DF/HCC may my protected health information be
shared?
While all reasonable efforts will be made to protect the confidentiality of your
protected health information, it may also be shared with the following entities:


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Outside individuals or entities that have a need to access this information to
perform functions relating to the conduct of research such as analysis by
outside laboratories on behalf of DF/HCC and its affiliates (for example,
data storage companies, insurers, or legal advisors).
The sponsor(s) of the study, its subcontractors, and its agent(s): its
collaborators and licensees
Other research doctors and medical centers participating in the screening, if
applicable
Federal and state agencies (for example, the Department of Health and
Human Services, the Food and Drug Administration, the National Institutes
of Health, and/or the Office for Human Research Protections), or other
domestic or foreign government bodies and other appropriate government
agencies if required by law and/or necessary for oversight purposes. A
qualified representative of the FDA and the National Cancer Institute may
review your medical records.
DF/HCC Institutional Review Board
Hospital accrediting agencies
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
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Content Last Revised with OHRS Review:
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Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
Some who may receive your protected health information may not have to
satisfy the privacy rules and requirements. They, in fact, may share your
information with others without your permission.
5. For how long will protected health information about me be used or
shared with others?

The protected health information will be stored until it is determined whether
or not you will participate in a research study based upon the results of the
screening procedures.
6. Statement of privacy rights:


While you may withdraw from participating in the screening procedures at
any time, without putting anything in writing, your right to withdraw your
permission for the research doctors and participating DF/HCC entities to
use or share your protected health information must be in writing. We will
not be able to withdraw all the information that already has been used or
shared with others to carry out related activities such as oversight, or that is
needed to ensure quality of the screening procedures. To withdraw your
permission, you must do so in writing by contacting the doctor listed above
in the section: “Whom do I contact if I have questions about the screening
procedures?”
You have the right to request access to your protected health information
that is used or shared during this screening process and that is related to
your treatment or payment for your treatment. To request this information,
please contact the doctor listed above in the section: “Whom do I contact if I
have questions about the screening procedures?
N. DOCUMENTATION OF ASSENT
[Delete this Assent Section if the research DOES NOT involve children or if you
expect Assent will not be required by the IRB.]
Signature of participant between age of 10 and 18: The person doing this
research study has explained what will happen to me if I take part in this research
study. My signature below means that I want to be in this research study. I can
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
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Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
decide not to take part in this research study if I do not want to and nothing will
happen to me if I decide I do not want to participate.
____________________________________ __________________
Signature of Participant
Date
To be completed by person obtaining assent:
The assent discussion was initiated on
(date).
The information was presented in age-appropriate terms. The minor:
Agreed to take part in the study
Did not agree to take part in the study
An assent discussion was not initiated with the minor for the following reason(s):
Minor is incapacitated
Minor is under 10 years of age
Other
Signature of Individual obtaining assent:
Printed name of above:
Date:
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
TBD
Date DFCI IRB Approval Expires:
TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
O. DOCUMENTATION OF CONSENT
My signature below indicates:
 I have had enough time to read the consent and think about participating
in this study;
 I have had all of my questions answered to my satisfaction;
 I am willing to participate in this study;
 I have been told that my participation is voluntary and I can withdraw at
any time
Signature of Participant
or Legally Authorized Representative
Date
Relationship of Legally Authorized Representative to Participant
[Please include the second signature line below ONLY if the IRB has determined
that a second signature is required.]
My signature below indicates:
 I have had enough time to read the consent and think about participating
in this study;
 I have had all of my questions answered to my satisfaction;
 I am willing to participate in this study;
 I have been told that my participation is voluntary and I can withdraw at
any time
Second Signature of Legally Authorized Representative
Date
Relationship of Legally Authorized Representative to Participant
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
TBD
Date DFCI IRB Approval Expires:
TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
Adult Participants
To be completed by person obtaining consent:
The consent discussion was initiated on
(date).
Signature of individual obtaining consent:
Printed name of above:
Date:
A copy of this signed consent form will be given to the participant or legally authorized
representative, or, where the participant is a minor, the participant’s parent or legal guardian.
For Adult Participants
1) The participant is an adult and provided consent to participate.
1a) Participant (or legally authorized representative) is a non-English speaker and
signed the translated Short Form in lieu of English consent document:
As someone who understands both English and the language spoken by the participant, I
interpreted and/or witnessed, in the participant’s language, the researcher’s presentation of
the English consent form. The participant was given the opportunity to ask questions.
Signature of Interpreter/Witness:
Printed Name of Interpreter/Witness:
Date:
1b) Participant is illiterate
The consent form was read to the participant who was given the opportunity to ask questions.
Signature of Witness:
Printed Name of Witness:
Date:
2) The participant is an adult who lacks capacity to provide consent and his/her legally
authorized representative:
2a) gave permission for the adult participant to participate
2b) did not give permission for the adult participant to participate
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Screening Procedures
Dana-Farber/ HarvardCancerCenter
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS Version: 07.17.1515
Minor Participants
To be completed by person obtaining consent:
The consent discussion was initiated on
(date).
Signature of individual obtaining consent:
Printed name of above:
Date:
A copy of this signed consent form will be given to the participant or legally authorized
representative, or, where the participant is a minor, the participant’s parent or legal guardian.
The parent or legally authorized representative gave permission for the minor to participate.
Parent or legally authorized representative is a non-English speaker and signed
the translated Short Form in lieu of English consent document
As someone who understands both English and the language spoken by the participant, I
interpreted and/or witnessed, in the participant’s language, the researcher’s presentation of
the English consent form. The participant was given the opportunity to ask questions.
Signature of Interpreter/Witness:
Printed name of Interpreter/Witness:
Date:
Parent or legally authorized representative is illiterate
The consent form was read to the parent or legally authorized representative
who was given the opportunity to ask questions.
Signature of Witness:
Printed Name of Witness:
Date:
The parent or legally authorized representative did not give permission for the minor to
participate
[Delete this box if the research involves adults only.]
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DFCI Protocol Number:
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Date DFCI IRB Approved this Consent Form:
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Date Posted for Use:
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Date DFCI IRB Approval Expires:
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OnCore Version Date:
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Content Last Revised with OHRS Review:
TBD