Download Biomedical Consent Template

Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
Protocol Title:
[If required by the sponsor you may add the Sponsor Protocol Number
here (the sponsor protocol number may not be placed anywhere else on this
document):
[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.]
[Descriptor If there is more than one consent form used for this protocol, insert a
descriptor here, e.g., Consent for Optional Biopsies, or Consent for Phase II, etc.
Please then describe below only what applies to the part of the study that is
described here]

If you are using the Prospective Collection of Human Material and/or Clinical
Data for Research Purposes Application, please use the Social/Behavioral
Research Consent Form.
NOTES to Informed Consent Authors:
This template contains DF/HCC recommended language for informed consent
documents. Informed consent authors should avoid changing this text except
where it is not relevant or appropriate to a specific protocol.

Model text for use in the informed consent form is in black text. In most cases
the black text should be retained when adapting the template to a specific
protocol. However, for some types of studies, the language may not be
appropriate. If you have questions about the applicability of text in this
template, please contact the Office for Human Research Studies (OHRS) at
(617) 632-3029.

Instructions and examples for informed consent authors are in [brackets and
italics]. A blank line, ______, is used where the information to be inserted is
clear.
Page 1 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017

The term “research doctor” has been used throughout the template because
the Principal Investigator of a cancer treatment trial is a physician. If this
template is used for a trial where the Principal Investigator is not a physician,
another appropriate term should be used instead of “research doctor”.

Once completed, please delete all instructions, i.e., blue text – these
statements are provided for guidance to consent writers only. After deleting
instructions, please review the consent form for proper formatting and
eliminate orphan heading (i.e., where the heading is printed by itself at the
bottom of a page and the text follows on the next page).

OPTIONAL STUDIES: Whenever possible, the IRB prefers that the optional
studies be incorporated into the main consent under a separate section,
rather than in a separate document (see Section P below).

COMBINATION PHASE STUDIES (e.g. Phase I/II): Generally, the IRB will
review separate consent forms for each phase of the study. Only the consent
form for the phase that is open needs be submitted. For instance, please
only submit the Phase I consent with the New Project Application, and then
submit the Phase II consent with an Amendment when that phase is opening.
Please contact OHRS if both the Phase I and Phase II portions will be open to
enrollment concurrently.

Please do not use the word “treatment” when referring to the “study drug.”
Please use “study drug,” “study agent,” “study drug administration,” etc. as
appropriate.

SHARING TISSUE/DATA WITH COMMERCIAL ENTITIES: When sending
the data or tissue with commercial entities, please make sure that the protocol
states with whom identified and de-identified information will be shared.
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
You are invited to take part in a clinical trial, a type of research study, because
you have ____ [State the general disease to be studied, for example: colon
cancer] [Describe specifically the type/stage/presentation of the disease being
studied here. For example: “Colon cancer that has spread and has not
responded to standard treatment.”] This research study is studying a ____ [State
Page 2 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
the primary study [drug/device/intervention] modality, for example:
chemotherapy, surgical [drug/device/intervention], targeted therapy, etc.] as a
possible treatment for this diagnosis.
The names of the study [drug/device/intervention](s) involved in this study are/is:
 [insert name of study [drug/device/intervention] #1, e.g.: XYZ-123987]
 [insert name of [drug/device/intervention] #2: e.g. Surgical Removal of the
Lymph Nodes]
 [insert name of [drug/device/intervention] #3: e.g. Stem Cell Transplant]
 etc.
For purposes of this research, you will be referred to as a “participant”.
It is expected that about ____ [state the total number at all participating centers]
people will take part in this research study.
_______ [name of sponsor or supporter; please also briefly define the sponsor,
e.g., “XXX, a pharmaceutical company,”] is supporting this research study by
providing ____ [funding for the research study, the study drug, study procedures,
etc.].
[If an institutional conflict of interest or study team member conflict of interest has
been identified by the Dana-Farber Cancer Institute Office of Research Integrity
and is subject to a management plan, please insert the appropriate consent
disclosure language here (as required under the terms of the management
plan).]
This research consent form explains why this research study is being done, what
is involved in participating in the research study, the possible risks and benefits
of participation, alternatives to participation, and your rights as a research
participant. The decision to participate is yours. If you decide to participate,
please sign and date at the end of this form. We will give you a copy so that you
can refer to it while you are involved in this research study. If you choose not to
participate in this research study, the research doctors will discuss other
treatment options with you and/or refer you back to your primary doctor.
We encourage you to take some time to think this over, to discuss it with other
people and your primary doctor, and to ask questions now and at any time in the
future.
Page 3 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
B. WHY IS THIS RESEARCH STUDY BEING DONE?
[Select the appropriate paragraph to include as appropriate for the Phase of the
study. This section should also clearly explain what portions of the protocol are
investigational / experimental as opposed to procedures that are done as
standard of care.]
[For Phase I studies, include the following:]
This research study is a Phase I clinical trial, which tests the safety of an
investigational [drug//device/intervention] and also tries to define the appropriate
dose of the investigational [drug/device/intervention] to use for further studies.
“Investigational” means that the [drug/device/intervention] is being studied.
[For Phase I/II studies in Phase I, include the following:]
This is a Phase I/II clinical trial. You are being asked to participate in the Phase I
portion of the study. A Phase I clinical trial tests the safety of an investigational
[drug/device/intervention] and also tries to define the appropriate dose of the
investigational [drug/device/intervention] to use for further studies.
“Investigational” means that the [drug/device/intervention] is being studied.
[For Phase I/II studies in Phase II, include the following:]
This is a Phase I/II clinical trial. You are being asked to participate in the Phase
II portion of the study. Phase II clinical trials test the safety and effectiveness of
an investigational [drug/device/intervention] to learn whether the
[drug/device/intervention] works in treating a specific disease. “Investigational”
means that the [drug/device//intervention] is being studied.
[For Phase II studies, include the following:]
This research study is a Phase II clinical trial. Phase II clinical trials test the
safety and effectiveness of an investigational [drug/device/intervention] to learn
whether the [drug/device/intervention] works in treating a specific disease.
“Investigational” means that the [drug/device/intervention] is being studied.
[For Phase II/III studies in Phase II, include the following:]
This is a Phase II/III clinical trial. You are being asked to participate in the Phase
II portion of the study. Phase II clinical trials test the safety and effectiveness of
an investigational [drug/device/intervention] to learn whether the
[drug/device/intervention] works in treating a specific disease. “Investigational”
means that the [drug/device/intervention] is being studied.
Page 4 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
[For Phase III studies:]
This research study is a Phase III clinical trial. Phase III clinical trials examine
the safety and effectiveness of a drug or treatment, often comparing it to another
known treatment.
[For Phase II/III studies in Phase III, include the following:]
This is a Phase II/III clinical trial. You are being asked to participate in the Phase
III portion of the study. Phase III clinical trials examine the safety and
effectiveness of a drug or treatment, often comparing it to another known
treatment.
[For Phase IV studies (including Phase III/IV studies in Phase IV) include the
following:]
This research study is a Phase IV clinical trial, which tests the safety and
effectiveness of an investigational combination of drugs, each of which have
been previously approved for use by the FDA to treat your specific disease.
[If this is a Single Patient IND, include the following:]
This research study is a Single Patient IND study, which is a way to provide an
investigational therapy to an individual patient who is not eligible to receive the
investigational therapy on an available clinical trial. To be eligible for a single
patient IND, the patient has to have a serious or life-threatening illness for which
no other treatments are available.
[If this is an Expanded Access Trial, include the following:]
This research study is an Expanded Access Trial, which is a way to provide an
investigational therapy to individuals who are not eligible to receive that therapy
in a clinical trial, but have a serious or life-threatening illness for which other
treatments are not available. Expanded access trials allow individuals to receive
promising but not yet fully studied or approved treatments when no other
treatment option exists.
[If this is a Pilot Study, include the following:]
This research study is a Pilot Study, which is the first time investigators are
examining this study [drug/device/intervention].
[If this is a Feasibility Study, include the following:]
This research study is a Feasibility Study, which is the first time investigators are
examining this study [drug//device/intervention].
Page 5 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
[If this is an Emergency Use Study, include the following:]
This research study is an Emergency Use Study, which is a way to provide an
investigational therapy to an individual patient in a life-threatening situation in
which no standard acceptable treatment is available and in which there is not
sufficient time to obtain Institutional Review Board (IRB) approval prior to
treatment. An IRB is a group of individuals that review and approve the detailed
plan for the research before it starts. IRBs are intended to protect participants in
research by ensuring the trial is well designed and ethical. IRBs also weigh the
risks and the benefits and review the investigators safety plan. After the
investigational therapy is administered the investigator will notify the IRB of the
Emergency Use.
[If the [drug/device/intervention] is FDA regulated but NOT FDA approved for any
use, please include the following:]
The FDA (the U.S. Food and Drug Administration) has not approved [specify the
drug/device name] as a treatment for any disease.
[If the [drug/device/intervention] is FDA regulated and FDA Approved, but not
FDA approved for this indication, please include the following:]
The FDA (the U.S. Food and Drug Administration) has not approved [specify the
drug/device name] for your specific disease but it has been approved for other
uses.
[If the [drug/device/intervention] is FDA regulated and FDA Approved for this
indication, please include the following:]
The FDA (the U.S. Food and Drug Administration) has approved [specify the
drug/device name] as a treatment option for your disease.
[If this is a first in human study, include the following:]
This is the first time that [specify the drug/device name] will be given to humans.
[If this is a first in children study, include the following:]
This is the first time that [specify the drug/device name] will be given to children.
[Please explain in lay language why this study is being done and what you
hope to learn from the research, include the following information:
Page 6 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
In this research study, we are...
 What is the name of the [drug/device/intervention] that is being studied;
 How was the [drug/device/intervention] developed or identified as a
possible treatment;
 How is the [drug/device/intervention]expected to treat the disease;
 Specify whether the [drug/device/intervention]been used as a treatment
for another disease, or if it has only been tested in laboratory experiments;
 Explain what information was learned from any prior uses / investigations;
 Describe what you are hoping to learn in this research (e.g. looking for the
highest dose that can be given safely or whether it works in combination
with other drugs, etc.]
C. WHAT OTHER OPTIONS ARE THERE?
Taking part in this research study is voluntary. Instead of being in this research
study, you have other options which may include the following [include in bulleted
format only those items that are appropriate; delete and/or reorder bulleted
items as appropriate for this participant population or this research study. For
example, if participants would not be candidates for palliative care outside the
research context, do not include the “comfort care” bullet as an option]:





Receive standard treatment including ____ [specify the standard
treatment].
Take part in another research study.
Receive the same drugs, but not as part of a research study. [If there
are multiple drugs used in the study, specify which may be available off
study.]
Receive no therapy specific to your cancer.
Comfort care, also called palliative care. This type of care may help to
reduce pain, tiredness, appetite problems and other problems caused
by the cancer. It does not treat the cancer directly, but instead tries to
treat the symptoms.
Please talk to the research doctor about your options before you decide whether
you will take part in this research study.
Page 7 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
D. WHAT IS INVOLVED IN THE RESEARCH STUDY?
[Instructions:
 Please describe each study procedure in bullet format so the participants
understand what will happen and then use a table to specify when the
procedures will occur.
 Please also make sure to define the length of a cycle in days or weeks.
 Specific instructions about how to take the drug, vomited and missed
doses, etc., should not be included in the consent form but should be
included in a separate drug diary/participant handout.]
[For dose escalation studies, insert the following:] Since we are looking for the
highest dose of the study drug that can be administered safely without severe or
unmanageable side effects in participants that have [insert disease name], not
everyone who participates in this research study will receive the same dose of
the study drug. The dose you get will depend on the number of participants who
have been enrolled in the study before you and how well they have tolerated their
doses.
[For randomized studies, insert the following:] Because no one knows which of
the study options is best, you will be “randomized” into one of the study groups:
____ [describe the groups]. Randomization means that you are put into a group
by chance. [Include the following only if randomization is 1 to 1: It is like flipping a
coin.] Neither you nor the research doctor will choose what group you will be in.
[If blinded include the following: “Neither you nor the research doctor will know
what group you are in.”] You will have a ____ [equal/one in three/etc.] chance of
being placed in any of the following groups:
[Describe each study group, for example:
 Group A: Standard Chemotherapy for 12 treatments plus placebo
 Group B: Standard Chemotherapy for 12 treatments plus study drug
 Group C: Standard Chemotherapy for 6 treatments plus placebo
 Group D: Standard Chemotherapy for 6 treatments plus study drug]
[For placebo studies, insert the following:] You will be given a study medication
and it will contain either ____ [name of drug] or placebo (pills with no medicine).
Page 8 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
[If applicable, include the following information here: Please explain whether the
study drug will or will not be available after the study ends.]
Sometimes it is hard to keep track of all of the details and procedures that are
part of a research study. We will describe them in this consent form and you can
refer to this at any time during the research study.
[If applicable, include information about any study visits that may be excessively
long especially if the visit will be more than several hours and/or require an
overnight stay.]
Before the research starts (screening):
After signing this consent form, you will be asked to undergo some screening
tests or procedures to find out if you can be in the research study. Many of these
tests and procedures are likely to be part of regular cancer care and may be
done even if it turns out that you do not take part in the research study. If you
have had some of these tests or procedures recently, they may or may not have
to be repeated.
[List all screening tests and procedures, using a bulleted format. Where
appropriate, please briefly state that samples will be coded and destroyed]
 A medical history, which includes questions about your health, current
medications, and any allergies.
 Performance status, which evaluates how you are able to carry on with
your usual activities.
 An assessment of your tumor by one or more of the following standard
assessment tools: X-ray, CT (Computerized Tomography) scan, MRI
(Magnetic Resonance Imaging) or PET (Positron Emission Tomography)
scans
 Blood tests.
 Urine test.
 Your previously collected and stored tissue (archival tissue) will be
obtained for tests. No additional tissue will be collected.
 [add additional tests as appropriate (e.g. DCE-MRI (Dynamic Contrast
Enhanced-Magnetic Resonance Imaging) scans].
Page 9 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
If these tests show that you are eligible to participate in the research study, you
may begin the study treatment. If you do not meet the eligibility criteria, you will
not be able to participate in this research study.
Additional research procedures to be performed at the time of screening
but not required to determine eligibility:
[This section typically lists the procedures that must be completed before
registration, but are not procedures to determine eligibility – if not applicable,
please delete section.]
 Blood tests, [if appropriate: including baseline tests so that we can
measure any additional effect of the study drug and disease status],
[and/or if appropriate add: or to look for a marker for your particular type of
cancer.]
 Pharmacokinetic (PK) blood samples: PK blood samples to monitor
how your body absorbs and breaks down the study drug. Each blood
sample will be approximately ___ teaspoon.
 HIV tests, [if appropriate: You will have blood samples (about 2
tablespoons) taken to test for HIV (human immunodeficiency virus). The
purpose of this routine laboratory test is to determine whether the virus
that is associated with Acquired Immune Deficiency (AIDS) that harms the
immune system is present in your blood. The results of these tests will
appear in your medical record and will be shared with health care workers
involved in your care. The test results will be shared with the study
sponsor(s)to perform functions relating to the conduct of this research. All
positive results will be shared with a health authority (e.g., the State
Department of Health) as required by law.]
Study Treatment Overview:
 Oral Study Drug(s): Each study treatment cycle lasts _____ weeks/days
during which time you will be taking the study drug ____ times per day.
This will continue for up to ____ days/weeks/months/cycles/years.
 Infused Study Drug(s): You will be given the study treatment(s) once
every ___ days/weeks into your vein (by intravenous infusion) over about
___ minutes/hours. This will continue for up to ___ weeks/cycles.
 Pre-medications: You may be pre-medicated with drugs to reduce the
chance of having a sensitivity reaction to the study treatment. If you
tolerate the study treatment without a reaction, then pre-medications may
be changed by your doctor.
Page 10 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
If a drug diary will be given please include the following: If you take part in this
research study you will be given a drug diary. You will be asked to document
information in the drug diary about the study treatment you are being asked to
take.
If a study calendar will be given, please include the following: If you take part in
this research study you will be given a study calendar. Information about what to
expect during and between study visits will be included in the study calendar.
[Instructions: Duplicate the Study Visit section as many times as needed. Please
list all tests and procedures, using the template language in bulleted format as
shown below. Where appropriate, please briefly state that samples will be coded
and destroyed.]
Study Visit: [Add here a Visit Description (e.g. Before Study Treatment Begins,
Day 1 of Each Cycle, Cycle 3, Day 15, or After Study Treatment Ends)]
[If appropriate, please describe the study visit here in paragraph form.]
This visit will involve the following:
 Oral Study Drug(s)
 Infused Study Drug(s)
 Clinical Exams: During this visit you will have a physical exam and you
will be asked questions about your general health and specific questions
about any problems that you might be having and any medications you
may be taking.
 Performance status, which evaluates how you are able to carry on with
your usual activities.
 Scans (or Imaging tests): We will assess your tumor by ___ [the
appropriate imaging modality, e.g., CT scan or MRI, etc.]
 Photographs: Photographs will be taken of your tumor to assess the
response of your tumor to the treatment. Care will be taken to ensure
these do not reveal your identity.
 Blood tests.
 Urine test.
 Tumor biopsies. [Please describe in detail what is involved. If a separate
consent form will be signed for the biopsy procedure, please state this
here.]
Page 11 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates

OHRS 02.03.2017
[Add here as necessary.]
Research Study Plan:
[If appropriate, include a simple table. The schema from the protocol should not
be used as it is usually too complex. The main purpose of the table is to tell
participants when the procedures described above will be conducted.]
Example of a simplified chart:
Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Every 4 Every 8 Final
Screening Day 1 Day 15 Day 29 Day 57 weeks weeks Visit
Medical History &
Physical Exam
Blood Test
CT Scan
Bone Marrow
Biopsy
Tumor Biopsy
Pregnancy Test
Urine Test
EKG
Receive Study
[Drug/Intervention]
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
Planned Follow-up:
[Explain the follow-up procedures. For example: We would like to keep track of
your medical condition. We would like to do this by [e.g., calling you on the
telephone once a year to see how you are doing]. Keeping in touch with you and
checking your condition helps us look at the long-term effects of the research
study.].
E. HOW LONG WILL I BE IN THIS RESEARCH STUDY?
You will be in this research study for up to [estimated length of time].
[Or – you will be on the study treatment for up to _________ [include either a
time period, such as 6 months, or event, such as “for as long as you do not have
Page 12 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
serious side effects and your disease does not get worse”] and will be followed
for __________ [e.g., 3 years].]
You may be taken off the research study [drug/device/intervention] for many
reasons including if:
 It is considered to be in your best interest
 The study treatment or procedures are found to be unsafe or ineffective
 There is any problem with following study treatments and procedures
 [Include only if appropriate:] You are a female and become pregnant or
plan to become pregnant
 Your condition worsens
 A decision is made to close the study
 Or for other unforeseen reasons that make it necessary to stop your
participation in the research study
If you are removed from the research study, the research doctor will explain to
you why you were removed. [Include, if appropriate what will happen if the
participant is removed from the study, e.g. “The research doctor and research
team will help arrange for your continued care. If you are removed from the
research study, you may be followed for up to one year. You may continue on
study treatment in the extension phase of the research study, if your research
doctor determines that you are showing evidence of clinical benefit from the
treatment.”]
In addition, you can stop participating in the research study at any time, however,
the FDA requires that any information collected up to the point of your withdrawal
cannot be removed from the study. If you decide to stop participating in this
research study, we encourage you to talk to the research doctor and your
primary doctor first.
F. WHAT ARE THE RISKS OR DISCOMFORTS OF THE RESEARCH STUDY?
[There is specific language that must be included in consent forms for research
that involves gene transfer and retroviral drugs. The institutional biosafety
offices will provide this language.]
[Standard language – use only when appropriate for the study:] There are risks
to taking part in any research study. One risk is that you may get a study drug
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for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
[for dose escalating studies include: or study dose of a drug] that does not help
treat your disease or that makes your condition or disease worse. Another risk is
that there may be side effects.
All cancer treatments can have side effects, which can range from mild and
reversible to severe, long lasting and possibly life-threatening. There is a great
deal of variability among side effects of different cancer treatments and between
individuals. In a research study, all of the risks or side effects may not be known
before you start the study. You need to tell your doctor or a member of the
study team immediately if you experience any side effects.
Everyone in the research study will be watched carefully for side effects. You will
be monitored during the administration of study drugs to keep track of your blood
counts and organ function, particularly your kidney and liver function. If you
experience side effects, they may go away after you stop taking the study drug.
Some side effects can be mild; but others can be long lasting and may never go
away. Some may be life-threatening or fatal.
Since the effect of the study drug(s) taken with other medications may not be
known, it is important that you tell the research doctor about all prescription and
non-prescription drugs, herbal preparations and nutritional supplements that you
are taking or planning to take. There may also be some foods that you should
avoid while on this research study and your research doctor will review this
information with you.
During the research study, you will be notified of newly discovered side effects or
significant findings, which may affect your health or willingness to participate.
You may be asked to sign a new consent form that shows that you have been
informed of new information relating to this research study.
[List the side effects using lay language in the categories below according to the
likelihood of occurrence.
 Indicate what the side effect means for the participant (e.g., abnormal
blood tests showing liver damage which is usually reversible when the
drug is stopped or dose reduced).
 Give information on the reversibility of the side effect.
 Do not use symbols like “<” or “>”. Instead use the terms “less than” or
“greater than” or whatever is most appropriate for the symbol being
replaced.
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for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
 Please format the bullets under each risk using lay terminology. Please
avoid using technical medical terms unless they are the term used in
speaking with subjects (in which case the term can be listed in
parentheses following the lay language description).
 Please do not include information that will become out of date or need to
be updated. For example, instead of stating “Of the thirty individuals who
have received this drug to date, ten have experienced the following side
effects…” please generally state: “The following side effects have been
experienced by individuals who have received this drug:” Similarly, instead
of stating “one participant experienced xyz…”, please include these risks
under the rare risks.
 Please refer to the NCCN Informed Consent Language Database for lay
terminology: http://www.nccn.org/clinical_trials/informed_consent.aspx
 If there are required drug/device/interventions associated with the
administration of the study drug, then those risks should also be included.
For example, if the administration of the study drug requires the placement
of a central line, then include those risks.
NOTE for Cooperative Group Trials Only: (i.e., CALGB, ECOG, CTSU,
NABTT, COG, etc.) Highly recommend presenting the risks as set forth in the
model consent document and not cutting and pasting those risks into the format
below. You may use your discretion in deciding whether to simply use the risk
format in the cooperative group model consent. This often is both the most
straightforward way to handle this, avoids potentially missing toxicities that are
essential to include for cooperative groups and will be easier to maintain with
future amendments. Please note that similar or related risks may be consolidated
into one bullet and risks should always be presented using lay terminology that is
meaningful to participants.
NOTE for Phase I Trials: Where known, the percentages, grouped as outlined
below, should be used to categorize risks associated with drugs used in the trial.
Also, if first in man consider including a statement that not all risks are known.
NOTE for Phase II and III Trials: Percentages should be used to categorize
risks associated with drugs in Phase II and Phase III trials. As a guideline, "likely"
risks are those occurring in greater than 50% of patients; “frequent” in 10-50% of
participants; “occasional” in 1-10%; and “rare” in less than 1%. However, if the
exact percentages are not known, then the terms likely, frequent, occasional, and
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Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
rare can be used without including the associated percentage categories. You
should be sure to identify those side effects that may be “serious.” Serious is
defined as side effects that may require hospitalization or may be irreversible,
long-term, life threatening or fatal.
NOTE re what risks to include: Please list risks for the following:
 Risks associated with the investigational drug, device or biologic
 Risks associated with drugs or combination of drugs being evaluated as
part of the study regardless of whether they are used on or off label
 Risks associated with any procedures that will be performed only as part
of the research (i.e., the procedures would not be conducted if the
participant were not participating in the study)
 Risks associated with any procedures required to administer the drugs,
e.g., placement of a central line. ]
Risks Associated with [Study [drug/device/intervention] Name]:
Likely [If applicable, add: (More than a 50% chance that this will
happen)]
 [List risks using a bulleted format with the most significant risks listed
first. Make sure that you use lay language to describe a risk.]
Frequent [If applicable, add: (Between a 10-50% chance that this will
happen)]
 [List risks using a bulleted format with the most significant risks listed
first. Make sure that you use lay language to describe a risk.]
Occasional [If applicable, add: (Between a 1-10% chance that this will
happen)]
 [List risks using a bulleted format with the most significant risks listed
first. Make sure that you use lay language to describe a risk.]
Rare [If applicable, add: (Less than a 1% chance that this will happen)]
 [List risks using a bulleted format with the most significant risks listed
first. Make sure that you use lay language to describe a risk.]
[Include the following paragraph if the study involves research biopsies,
scans or x-rays.] Cancer research often includes biopsies, scans, x-rays that
are also provided as routine care. The following describes the side effects of
procedures done only for the purposes of research.
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Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
Risks Associated with Biopsies:
[For studies that involve biopsy of tissue other than bone marrow, use the
following language. Include only what pertains to the research study.]
Biopsies are normally performed under the guidance of an imaging technique.
Each procedure requires a separate consent prior to the biopsy. The risks may
include:
 Pain and discomfort. The amount of pain and discomfort will vary,
depending on the location of the biopsy site. These risks can be discussed
with the study doctor.
 Minor bleeding at the biopsy site.
 Tenderness at the biopsy site.
 Scarring at the biopsy site.
 Rarely, an infection at the biopsy site.
[If applicable insert the following:] Uncommonly, complications from biopsies can
be life threatening. As with any interventional procedure, other potentially serious
complications from bleeding or organ damage may occur. These might require
additional surgical intervention.
Risks Associated with Bone Marrow Biopsies:
[For studies that involve bone marrow biopsies, use the following language.]
For this procedure, a numbing drug is injected into the skin over one of your
hipbones. A needle is then inserted into the hipbones and a small piece of bone
is removed. The risks may include:
 Moderate pain and discomfort
 Bleeding at the biopsy site
 Scarring at the biopsy site
 Rarely, an infection at the biopsy site
 Rarely, nerve injury at the biopsy site
Risks Associated with Bone Marrow Aspiration:
[For studies that involve bone marrow aspiration, use the following language.]
For this procedure, a numbing drug is injected into the skin over the same
hipbone. A needle is then inserted into the hipbone and a sample of bone
marrow fluid is removed. Risks of this procedure are small, but may include:
 Pain from the needle sticks
 Pain from aspirating the bone marrow with a syringe
 Bleeding
 Infection
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Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates

OHRS 02.03.2017
Local nerve damage
Radiation Risks Associated with Scans and X-Rays:
[This language will be reviewed by the appropriate Radiation Safety Offices and
should be consistent with the Radiation Safety Screening Form. Only include if
the scans are not standard of care.] While you are in this research study, CT
scans, PET/CT scans, Bone Scans, x-rays, mammograms, and/or other scans
utilizing radioactivity [Include only those scans/x-rays that are applicable.] may be
used to evaluate your disease. [If applicable, please include:] In the long term,
over many years, there is a very low risk of developing a new cancer as a result
of the radiological evaluation and treatment for your cancer.
[Include if appropriate and the risk is actually described above:] Certain types of
drugs or combinations of these drugs with radiation may further slightly increase
the risk of developing a new cancer. This risk is described above, in the section
about the risks associated with [study drug(s)].
Risks Associated with Mammograms:
[For studies that involve ONLY mammograms that are more frequent than
standard of care, you may use the following language. For studies that involve
mammograms and other radioactive agents, please add this language to the
previous section, “Risks Associated with Radiological Scans and X-Rays.”]
While you are in this research study, mammograms may be used to evaluate
your disease. [If scans are for research purposes state: The frequency of these
exams is greater than what you would receive as standard care. But if scans are
NOT for research purposes state: The frequency of these exams is about the
same as what you would receive as standard care.] There is thought to be a low
but increased risk of cancers associated with radiation in the long term over
many years.
[If done for screening purposes only, please include the following:] In addition,
there is a chance of having an abnormal mammogram. This could require further
testing with a breast biopsy and possible other tests. If you have an abnormal
mammogram, this could result in your needing a breast biopsy you would not
otherwise get. An abnormal mammogram may cause you to feel upset, worried,
or depressed. If you are upset, you may speak with the research doctor or ask to
be referred for additional emotional support.
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Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
Risks Associated with MRI Scans:
When having an MRI (Magnetic Resonance Imaging) scan, you will lie still on a
table that slides into a tunnel slightly wider than your body. People who feel
uncomfortable in confined spaces (claustrophobia) may feel uncomfortable in the
narrow cylinder. If you feel uncomfortable in confined spaces, please tell your
research doctor. Your doctor may give you a medication to make you feel more
comfortable. As images are taken, a loud banging noise will be produced.
Earplugs or headphones will be available if needed. The MRI can be stopped at
any time at your request, but the scan may not be complete.
[Include only if appropriate:]
Risks Associated with Contrast Agents Used During Scans:
[Include only if appropriate:] There is a small risk with using a contrast agent that
is injected into a vein during the ______ [indicate type of scan, eg. CT scan or
MRI]. The contrast agent is a special dye that highlights organs, blood vessels or
tissue to make them more visible. Depending on the type of contrast agent that
is used, it may cause decreased kidney function or worsen kidney function in
people who already have decreased kidney function. Therefore, we will monitor
your kidney function closely while you participate in this study. If there is any
change in your kidney function, we may have to remove you from the study.
[Include only if appropriate:] Uncommonly, some people have allergic reactions
(such as hives and itching) to the contrast agent. Serious reactions (for example,
drop in blood pressure, difficulty breathing or severe allergic reaction and death)
are rare.
Reproductive Risks:
[Include if appropriate:] The drugs used in this research study may affect a fetus.
While participating in this research study [include if appropriate: “and for XX
months after”], you should not become pregnant [delete for studies with only
male participants] or father a baby [delete for studies with only female
participants], and should not nurse a baby [delete for studies with only male
participants]. We can provide counseling about preventing pregnancy for either
male or female study participants. Let your doctor know immediately if you
become pregnant or find out that you are going to be the father of a child.
[When applicable, include the following:] In the event that your partner becomes
pregnant, it may be critical to share information regarding your participation in
this research study with that person. Your research doctor should also be told if
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Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
this happens. The study sponsor may want to collect data on your partner’s
pregnancy.
[For certain agents, such as thalidomide and related compounds, additional risks
should be included as appropriate.]
Non-Physical Risks:
[Include if appropriate:] Because of side effects or the time required for tests and
clinic visits while you are on this research study, you may be unable to keep up
with your normal daily activities.
[Include if appropriate:] The questionnaires used in this study may be upsetting. If
you find the questionnaires upsetting, you may speak with the research doctor or
ask to be referred for additional emotional support.
[Include if the research involves germline testing:]
Risks of Genetic Testing:
There is a risk that your test results could lead to genetic discrimination. A
Federal law, called the Genetic Information Nondiscrimination Act (GINA),
generally makes it illegal for health insurance companies, group health plans,
and most employers to discriminate against you based on your genetic
information. However, this law does not protect you against genetic
discrimination by companies that sell life insurance, disability insurance, or longterm care insurance. There may be other unknown privacy risks.
G. WHAT ARE THE BENEFITS OF THE RESEARCH STUDY?
[Please revise the following language as appropriate for the study.]
We do not know if taking part in this study will help you. This study may help
researchers learn information that could help people in the future.
H. CAN I STOP BEING IN THE RESEARCH STUDY 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 this research study.
You can stop being in the research study at any time. Tell the research doctor if
you are thinking about stopping or decide to stop. He or she will tell you how to
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Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
stop. Leaving the research study will not affect your medical care outside of the
research study.
If you choose not to participate, are not eligible to participate, or withdraw from
this research study, 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. [NOTE
for Cooperative Group Trials: Highly recommend presenting this paragraph as
set forth in the model consent document.]
It is important to tell the research doctor if you are thinking about stopping so
your research doctor can evaluate the risks from stopping the ____ [drug
/combination of drugs / device/intervention]]. [Please include the following
statement if there are risks associated with stopping the study drug abruptly: In
some cases, the abrupt stopping of a drug can have risks in itself.] Another
reason to tell your research doctor that you are thinking about stopping is to
discuss what follow-up care and testing could be most helpful for you.
I. WILL I BE PAID TO TAKE PART IN THIS RESEARCH STUDY?
[Please state whether participants will receive payment for participating in this
study. If they will receive payment, please describe. Please note that this section
should not be used to describe compensation for research related injuries which
is covered later in this consent form. Please include any informational handouts
regarding reimbursement for IRB review.]
[Include if applicable:] You will not be paid for participating in this study.
[Please include the following language, if applicable. Please do not include
details about the reimbursement plan:]
The study sponsor may reimburse you for qualifying study-related travel costs
and/or expenses. Study staff will review the reimbursement plan and any
requirements for reimbursement with you.
[When the research might lead to a medical discovery that could result in the
commercial development of a product or medical test, include the following
statement:] We may use your samples and information to develop a new product
or medical test to be sold. The sponsor and hospital may benefit if this happens.
There are no plans to pay you if your samples are used for this purpose.
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Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
J. WHAT ARE THE COSTS?
Taking part in this research study might lead to added costs to you or your
insurance company.
[NOTE: Please state whether the cost of the study drug will be covered. Please
do not list who will cover payment for costs for procedures because they might
conflict with the billing grids.]
[If appropriate, include the following] You will not be charged for ____ [insert
drugs]. [If appropriate, include the following] It is possible that ____ [insert drugs]
may not continue to be supplied free for some reason. If this would occur, your
research doctor will talk with you about your options.
[If this applies to your study, add this statement:] You or your insurance company
will be charged for portions of your care during this research study that are
considered standard care, [if applicable, add “including the following study
drugs….”]. You may be responsible for co-payments and deductibles that are
typical for your insurance coverage.
[For drugs that are commercially available, but used off label, please include
the following language if applicable (e.g., peer reviewed publications supporting
the off-label use). Please contact your clinical trials billing department if you
have questions: [Drug name] is commercially available which means that the
FDA has approved it for use in patients with another type of cancer. Because
there is evidence that supports using this drug in patients with your type of
cancer, you or your insurance company will be billed for the cost of _____[drug
name].]
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: [include only the relevant institutional
numbers]



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
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Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates



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
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

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Dana-Farber Cancer Institute: (617) 632-3455
Massachusetts General Hospital: (617) 726-2191
Beth Israel Deaconess Medical Center – Needham (BIDMC-Needham):
(617) 667-5661
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in clinical
affiliation with South Shore Hospital: (781) 624-4329
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
Dana-Farber Cancer Institute/Faulkner Hospital: (617) 632-3455
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 (1-800-422-6237)
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Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
K. WHAT HAPPENS IF I AM INJURED OR BECOME SICK BECAUSE I TOOK PART IN
THIS RESEARCH STUDY?
[Include the following required language. If the sponsor requests changes, note that the
IRB will not approve language that:
 Attempts to define a research-related injury (for example, by specifically
excluding pre-existing conditions and underlying disease)
 Attempts to impose standards of behavior on participants (for example,
“Sponsor will pay your costs if you followed the study team directions”)
 Attempts to limit the amount of coverage that will be provided (for example,
“Sponsor will pay your reasonable medical costs only,” or “Sponsor will not
pay for lost wages”)
 Includes legal or not lay-friendly terminology (for example, “Sponsor will not
pay if the investigator was negligent or engaged in willful misconduct”)
 Discusses the Sponsor’s obligations versus the institution’s (for example,
“Sponsor will not pay if the study team did not follow the protocol”)
 Appears contractual or is potentially exculpatory (for example, “You agree
that Sponsor is not responsible”)]
If you think you have been injured as a result of taking part in this research study,
tell the person in charge of this research study as soon as possible. The
research doctor’s name and phone number are listed in this consent form.
The treating hospital will offer you the care needed to treat injuries directly
resulting from taking part in this research. These treatments will be billed to your
insurance company. You will be responsible for deductibles and co-payments.
There are no plans to pay you or give you other compensation for the injury. You
do not give up your legal rights by signing this form.
We will need to collect certain personal information about you for insurance or
payment reporting purposes, such as your name, date of birth, gender, social
security number or Medicare identification number and information related to this
research study. We may be required to report this information to the Centers for
Medicare & Medicaid Services. We will not use this information for any other
purpose.
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Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
L. 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 study data.
[If medical information will become part of the hospital medical record include
then add this statement:] Medical information created by this research study may
become part of your hospital medical record and may be forwarded to your
primary doctor. Information that does not become part of your medical record will
be stored in your study file. [If this is a clinical trial where participants are
registered in OnCore then add this statement:] It may also become part of a
DF/HCC research database.
[When applicable add:] The results of this research study may be published. You
will not be identified in publications without your permission.
If the protocol involves the collection of tissue, please include the following
statement, “As participation in this study involves providing a specimen of your
tissue, please know that if the research doctor leaves the institution, the research
and the tissue might remain at the DF/HCC or might be transferred to another
institution.”
For all Clinical Trials registered on clinicaltrials.gov (DF/HCC SOP REGIST-200)
participants must be notified in the informed consent document that clinical trial
information has been or will be submitted for inclusion in the clinical trial registry
databank. The required statement is as follows:
[When applicable add without any modification to the language:] 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.
M. CERTIFICATE OF CONFIDENTIALITY
[Include this section ONLY if a Certificate of Confidentiality has been obtained for
the study. If you choose to also include sponsor language, please remove
duplicative information.]
This research study is being conducted by ____ [add name of organization
obtaining the certificate]. To help protect your privacy, ____ [add name of
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Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
organization obtaining the certificate] has obtained a Confidentiality Certificate
from the Department of Health and Human Services (DHHS).
With this Certificate, ____ [add name of organization obtaining the certificate]
cannot be forced (for example, by court subpoena) to disclose information that
may identify you in federal, state, or local civil, criminal, administrative, legislative
or other proceedings. Disclosure will be necessary, however, upon request of the
Department of Health and Human Services for audit or program evaluation
purposes.
You should understand that a Certificate of Confidentiality does not prevent you
or a member of your family or even the research doctor from voluntarily releasing
information about yourself or your involvement in this research. Note however,
that if an insurer or employer, learns about your participation, and obtains your
consent to receive research information, then ____ [add name of organization
obtaining the certificate] may not use the Certificate of Confidentiality to withhold
this information. This means that you and your family must also actively protect
your own privacy.
N. WHOM DO I CONTACT IF I HAVE QUESTIONS ABOUT THE RESEARCH STUDY?
If you have questions about the study, please contact the research doctor or
study staff as listed below:
[Add contact information for principal research doctor, research doctors and
study staff as appropriate for each site – use a bulleted format.
For example:
Dana-Farber Cancer Institute
 Chris Smith, MD: (617) 632-0000
 Pat Black, RN, NP: (617) 632-0000
Include a phone number and instructions on what to do if the participant needs to
contact study staff outside normal business hours, for example:
24-hour contact: Dana-Farber Cancer Institute: Chris Smith, MD at (617) 6320000 or page at (617) 632-0000 beeper 40000.]
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DFCI Protocol Number:
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Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
For questions about your rights as a research participant, please contact a
representative of the Office for Human Research Studies at Dana-Farber Cancer
Institute (617) 632-3029. This can include questions about your participation in
the study, concerns about the study, a research related injury, or if you feel/felt
under pressure to enroll in this research study or to continue to participate in this
research study.
O. 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 enroll in this research study, your “protected health
information” will 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 research?


Existing medical records, including mental health records.
New health information created from study-related tests, procedures,
visits, and/or questionnaires
2. Why will protected information about me be used or shared with others?
The main reasons include the following:
 To conduct and oversee the research described earlier in this form;
 To ensure the research meets legal, institutional, and accreditation
requirements;
 To conduct public health activities (including reporting of adverse events
or situations where you or others may be at risk of harm); and
 To provide the study sponsor with information arising from an adverse
event or other event that relates to the safety or toxicity of the drug(s)
used in the study and for the purpose of this or other research relating the
study drug(s) and their use in cancer;
 To better understand the diseases being studied and to improve the
design of future studies; and,
 Other reasons may include for treatment, payment, or health care
operations. For example, some medical information produced by this
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DFCI Protocol Number:
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Approved Date (DFCI IRB Approval):
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Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
research study may 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
research 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:







Outside individuals or entities that have a need to access this information
to perform functions relating to the conduct of this 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, representatives, business
partners, and its agent(s): ____ [enter the names of all sponsors] [Include
if applicable: The sponsor may send study data outside of the U.S.]
Other research doctors and medical centers participating in this research,
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 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.
Hospital accrediting agencies
A data safety monitoring board organized to oversee this research, if
applicable
Other, ____ [please specify]
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DFCI Protocol Number:
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Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
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?

There is no scheduled date at which your protected health information that
is being used or shared for this research will be destroyed, because
research is an ongoing process.
6. Statement of privacy rights:


You have the right to withdraw your permission for the research doctors
and participating DF/HCC entities to use or share your protected health
information. 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 study. To
withdraw your permission, you must do so in writing by contacting the
researcher listed above in the section: “Whom do I contact if I have
questions about the research study?”
You have the right to request access to your protected health information
that is used or shared during this research and that is related to your
treatment or payment for your treatment, but you may access this
information only after the study is completed. To request this information,
please contact the researcher listed above in the section: “Whom do I
contact if I have questions about the research study?”
P. OPTIONAL RESEARCH STUDIES:
[If there are no optional research studies or procedures, please delete this
section. If there are optional research studies or procedures, please briefly
describe them where indicated and for each optional study please include the
template lines for participants to indicate their choice. Please add as many
template Optional Study sections as needed including a sequential identification
number for each added Optional Study. Any optional studies described in this
consent form must also be described in the protocol.]
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DFCI Protocol Number:
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Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
You are being asked to participate in some optional studies. If you decide not to
participate in any of the optional studies, you can still participate in the main
research study. Please take your time to make your decision and discuss it with
others and your primary care physician.
Your participation in these optional research studies is voluntary, and you will not
be penalized or lose any benefits if you refuse to participate or decide to stop.
Optional Study #1:
[Please describe the first Optional Study here]
Please indicate whether or not you want to take part in this optional research
study.
 Not applicable
 Yes
Initials
Date
 No
Initials
Date
Optional Study #2:
[Please describe the second Optional Study]
Please indicate whether or not you want to take part in this optional research
study.
 Not applicable
 Yes
Initials
Date
 No
Initials
Date
Optional Study #3:
[Please describe the third Optional Study]
Please indicate whether or not you want to take part in this optional research
study.
 Not applicable
Page 30 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
 Yes
Initials
Date
 No
Initials
Date
Page 31 of 36
DFCI Protocol Number:
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Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
Q. 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 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:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
R. 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
Page 33 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
To be completed by person obtaining consent:
Adult Participant
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.
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 physically unable to sign the consent form because:
The participant is illiterate.
The participant has a physical disability.
Other (please describe): _________________________________________
The consent form was presented to the participant who was given the opportunity
to ask questions and who communicated agreement to participate in the research.
Signature of Witness:
Printed Name of Witness:
Date:
Page 34 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
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
To be completed by person obtaining consent:
Minor Participant
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.
1) The parent or legally authorized representative gave permission for the minor to
participate.
1a) 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:
1b) Parent or legally authorized representative is physically unable to sign the consent
form because:
The participant is illiterate.
The participant has a physical disability.
Other (please describe): _________________________________________
Page 35 of 36
DFCI Protocol Number:
TBD
Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD
Research Consent Form
for Biomedical Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates
OHRS 02.03.2017
The consent form was presented to the parent or legally authorized representative
who was given the opportunity to ask questions and who communicated agreement for
the minor to participate in the research.
Signature of Witness:
Printed Name of Witness:
Date:
1c) The parent or legally authorized representative did not give permission for the minor to
participate
Page 36 of 36
DFCI Protocol Number:
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Approved Date (DFCI IRB Approval):
TBD
Date Posted for Use:
TBD
Expiration Date (Invalid for use on or after): TBD
OnCore Version Date:
TBD
Content Last Revised with OHRS Review:
TBD