Research Consent Form Dana-Farber/ Harvard Cancer CenterBIDMC/BWH/CH/DFCI/MGH/Partners Network Affiliates OHRS 08.13.10 Protocol Title: 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.][DescriptorIf 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.] 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 anditalics]. A blank line, ______, is used where the information to be inserted is clear. • 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. Each optional studies section should include a separate section for the participant’s Page 1 of 27 DFCI Protocol Number: TBD Date DFCI IRB Approved this Consent Form: TBD Date Posted for Use: TBD Date DFCI IRB Approval Expires: TBD
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 adescriptor here, e.g., Consent for Optional Biopsies, or Consent for Phase II, etc.]
NOTES to Informed Consent Authors:
This template contains DF/HCC recommended language for informed consentdocuments. Informed consent authors should avoid changing this text exceptwhere 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 casesthe black text should be retained when adapting the template to a specificprotocol. However, for some types of studies, the language may not beappropriate. If you have questions about the applicability of text in thistemplate, 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 isclear.
• The term “research doctor” has been used throughout the template becausethe Principal Investigator of a cancer treatment trial is a physician. If thistemplate 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 – thesestatements are provided for guidance to consent writers only. After deleting
instructions, please review the consent form for proper formatting andeliminate orphan heading (i.e., where the heading is printed by itself at thebottom of a page and the text follows on the next page).
• OPTIONAL STUDIES: Whenever possible, the IRB prefers that the optionalstudies be incorporated into the main consent under a separate section. Eachoptional studies section should include a separate section for the participant’s
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initials and the date. This initial/signature section should be placed after theprivacy section and before the assent/consent documentation sections.
•COMBINATION PHASE STUDIES (e.g. Phase I/II): Generally, the IRB willreview separate consent forms for each phase of the study. Only the consentform for the phase that is open needs be submitted. Please contact OHRS if both the Phase I and Phase II portions will be open to enrollmentconcurrently.
• PHASE I and NON-TREATMENT STUDIES: Please do not use the word“treatment” when referring to the “study drug.” Please use “study drug,” “studyagent,” “study drug administration,” etc. as appropriate.
• TISSUE COLLECTIONS/OWNERSHIP: If the protocol involves the collectionof tissue, where appropriate, please include the following statement, “If
participation in this protocol involves providing a specimen of your tissue,please know that if the investigator leaves the institution, the research and thetissue might remain at the DF/HCC or might be transferred to another institution.”
• SHARING TISSUE/DATA WITH COMMERCIAL ENTITIES: When sending thedata or tissue with commercial entities, please make sure that the protocolstates 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 thisdocument 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. You areinvited to take part because you have ____ [type/stage/presentation of cancer being studied is briefly described here. For example: “colon cancer that hasspread and has not responded to standard treatment”] . This research study is away of gaining new knowledge about _____. If you decide to take part, you willbe known as a “participant” rather than a “patient”. This research study isevaluating a ____ [drug, device, etc.] called ____ [insert name of investigational
agent ] [do not include the following for phase I studies:] as a possible treatmentfor ____ [disease or condition] .
It is expected that about ____ [state the total number at all participating centers] people will take part in this research study. Some research studies are supported in some way by an outside organization.
_______ [name of sponsor or supporter] is supporting this research study by
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providing ____ [funding for the research study, the study drug, etc.].
This research consent form explains why this research study is being done, whatis involved in participating in the research study, the possible risks and benefitsof the research study, alternatives to participation, and your rights as a researchparticipant. 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 youcan refer to it while you are involved in this research study. If you choose not toparticipate in this research study, the research doctors will discuss other treatment options with you and/or refer you back to your regular doctor.
We encourage you to take some time to think this over, to discuss it with other people and your doctor, and to ask questions now and at any time in the future.
B. WHY IS THIS RESEARCH STUDY BEING DONE?
[Select the appropriate paragraph to include as appropriate for the Phase of thestudy. If the study is a combination phase study, e.g., Phase I/II, please only describe the applicable phase and a statement such as “This is a Phase I/II clinical trial. You are being asked to participate in the Phase II portion of thestudy. Phase II clinical trials…” Please contact OHRS if you have any questions.
This section should also clearly explain what portions of the protocol areinvestigational/experimental from regular cancer care, as appropriate.]
[For Phase I studies, include the following:] This research study is a Phase I clinical trial. Phase I clinical trials test the safetyof an investigational ____ [drug / combination of drugs / intervention] . Phase Istudies also try to define the appropriate dose of the investigational_____ [drug / combination of drugs / intervention] to use for further studies. “Investigational”means that the ____ [drug / combination of drugs / intervention] is still beingstudied and that research doctors are trying to find out more about it. It alsomeans that the FDA (U.S. Food and Drug Administration) has not approved ____ [drug / intervention] for your type of cancer. [ NOTE: If the study drug has not been approved for any use, please use “…has not approved ____ [drug /
combination of drugs / intervention] for use in patients, including people with your type of cancer.]
[For Phase II studies, include the following:] This research study is a Phase II clinical trial. Phase II clinical trials test theeffectiveness of an investigational ____ [drug / combination of drugs /
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intervention] to learn whether the ____ [drug / combination of drugs / intervention] works in treating a specific cancer. “Investigational” means that the
____ [drug / combination of drugs / intervention] is still being studied and that
research doctors are trying to find out more about it–such as the safest dose touse, the side effects it may cause, and if the ____ [drug / combination of drugs / intervention] is effective for treating different types of cancer. It also means thatthe FDA (the U.S. Food and Drug Administration) has not yet approved ____ [drug / combination of drugs / intervention] for your type of cancer. [ NOTE: If thestudy drug has not been approved for any use, please use “…has not approved
____ [drug / combination of drugs / intervention] for use in patients, including people with your type of cancer.]
[For Phase III studies, include the following:] This research study is a Phase III clinical trial. Phase III clinical trials compare
____ [e.g.: “the study drug with the treatment that is considered the standard of care for a disease” or “the results of two standard treatment options to see whichis better” or “different study treatments to see if one is better for treating the typeof cancer you have”] .
[Please briefly describe, using non-technical, terminology the rationale for thestudy, e.g., why and how researchers think the study drug will affect the cancer cells. Use plurals as appropriate.]
____ [the agent that is being studied] is a ____ [e.g., newly discovered compound/ a drug that may stop cancer cells from growing abnormally, etc.] . This
drug has been used in ____ [treatment for other cancers/other researchstudies/if phase I, laboratory experiments] and information from those other research studies suggests that this ____ [agent ] may help to ____ [explain what you want it to do] in this research study.
In this research study, we are ____ [describe what you are doing—looking for thehighest dose that can be given safely; looking to see how well it works incombination with other drugs, etc.].
C. WHAT OTHER OPTIONS ARE THERE?
Taking part in this research study is voluntary. Instead of being in this researchstudy, you have other options which may include the following [include in bulleted format only those items that are appropriate; delete bulleted items that are not appropriate for this participant population or this research study. For example, if
participants would not be candidates for palliative care outside the researchcontext, do not include the “comfort care” bullet as an option] :
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• Standard treatment including ____ [specify the standard treatment ].
• Participation in another research study.
• Receive the same drugs, but not as part of a research study.
• No therapy specific to your cancer.
• Comfort care, also called palliative care. This type of care may helpto reduce pain, tiredness, appetite problems and other problemscaused by the cancer. It does not treat the cancer directly, but insteadtries 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.
D. WHAT IS INVOLVED IN THE RESEARCH STUDY?
Sometimes it is hard to keep track of all of the details and procedures that arepart of a research study. We will describe them in this consent form and you canrefer to this at any time during the research study. [If appropriate, add – “ We willalso provide you with a chart [or, if applicable: a calendar ] or a calendar that willbe an easy reference for you to keep track of the procedures and when you takethe study drug in this research study.”]
Before the research starts (screening): After signing this consent form, youwill 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 tobe part of regular cancer care and may be done even if it turns out that you donot 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, for example:]
• A medical history, which includes questions about your health,current medications, and any allergies.
• Performance status, which evaluates how you are able to carry onwith your usual activities.
• An assessment of your tumor by X-ray, CT (Computerized
Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (PositronEmission Tomography) scans, [add additional tests as appropriate (e.g.DCE-MRI (Dynamic Contrast Enhanced-Magnetic Resonance Imaging)scans].
• Blood tests.
• Urine test.
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If these tests show that you are eligible to participate in the research study, youwill 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:[This section typically lists the procedures that must be completed beforeregistration, but are not procedures to determine eligibility:
• Blood tests, [if appropriate: including baseline tests so that we canmeasure 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.]
After the screening procedures confirm that you are eligible to participate
in the research study: [This section typically lists the procedures that must becompleted after registration.
Recommend that you describe the procedure so the participantsunderstand what will happen and then outline in a table when the
procedures will occur.
State whether the study drug will be available after the study ends.
Also, please include the length of clinic visits, especially when the visit will be several hours. Please also make sure to define the length of a cycle indays or weeks.]
Specific instructions about how to take the drug, vomited and missed
doses, etc., should be included in the drug diary and not in the informed consent document.
Sample text…
[For dose escalation studies, insert the following :] Since we are looking for thehighest dose of the study drug that can be administered safely without severe or unmanageable side effects in participants that have [insert disease name] , noteveryone 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 whohave 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 groupby chance. It is like flipping a coin. Neither you nor the research doctor willchoose what group you will be in. You will have a ____ [equal/one in three/etc.]
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chance of being placed in any group. [If blinded include the following: “Neither you nor the research doctor will know what group you are in.”]
[ For placebo studies, insert the following:] You will be given a study medicationand it will contain either ____ [name of drug ] or placebo (pills with no medicine).
Study Drug(s): If you take part in this research study, you will be given astudy drug-dosing calendar for each treatment cycle. Each treatment cyclelasts _____ weeks during which time you will be taking the study drug for
_____ (days or weeks) or on (days ___).
Clinical Exams: During all cycles you will have a physical exam and you willbe asked questions about your general health and specific questions aboutany problems that you might be having and any medications you may be
taking.
Scans (or Imaging tests): We will assess your tumor by ___ [theapprorpaite imaging modality, e.g., CT scan or MRI, etc.]
Photographs: Photographs will be taken of your tumor to assess theresponse of your tumor to the treatment. Care will be taken to ensure thesedo not reveal your identity.]
After the final dose of the study drug: [Explain the follow-up tests, procedures,
exams, etc. required, including the timing of each and whether they are part of standard cancer care or part of standard care but being performed more oftenthan usual or being tested in this research study. Indicate the length of follow-up. For example: “ We would like to keep track of your medical condition for therest of your life. We would like to do this by calling you on the telephone once ayear to see how you are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the researchstudy.”] .
Research Study Plan[If appropriate, include a study chart and/or schema (study plan). The schema
from the protocol should not generally be used as it is usually too complex;however, a simplified version of the schema is encouraged. The main purpose of the schema/chart is to tell participants when the procedures described above will be conducted.]
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You will be in this research study for about [estimated length of time] . [Or – you will be on the study treatment for about _________ [e.g., 6 months] and be followed for __________. [e.g., 3 years]]
The research doctor may decide to take you off the research study 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
• Your condition worsens
• 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 toyou 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 theresearch study, you may be followed for up to one year. You may continue onstudy treatment in the extension phase of the research study, if your researchdoctor determines that you are showing evidence of clinical benefit from thetreatment.”]
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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 withdrawalcannot 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 regular 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 researchthat involves gene transfer and retroviral drugs. Please contact OHRS for the specific regulatory language.]
[ Standard language – use only when appropriate for the study:] There are risksto taking part in any research study. One risk is that you may get a drug [for doseescalating studies include: or dose of a drug ] that does not help treat your disease or that makes your condition or disease worse. Another risk is that theremay be side effects.
All cancer drugs have side effects, which can range from mild and reversible tosevere, long lasting and possibly life-threatening. There is a great deal of variability among side effects of different drugs and between individuals. For investigational drugs, not all of the risks are known at this time. You need to tellyour doctor or a member of the study team immediately if you experienceany side effects.
Since many drugs used to treat cancer are designed to cause the rapidly dividingcancer cells in your body to slow down or die, these drugs can also cause other rapidly dividing normal cells in your body to slow down or die. These include theblood cells that help to fight infection (white blood cells), the blood cells that helpthe blood clot (platelets), and the blood cells that carry oxygen in your body (redblood cells). When anticancer drugs cause a decrease in these blood cells, it iscalled bone marrow suppression. While you are participating in this researchstudy, your blood cell levels will be monitored closely.
Please notify your doctor if any of the following occur:
• A fever of 100.5 or above.This could be a sign of an infection. If you have a low white bloodcell count, this can be serious, life-threatening or fatal. You mayhave to take antibiotics or be admitted to the hospital.
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• Low energy or shortness of breath.This could be a sign of anemia (not enough red blood cells). If thisbecomes severe, you may need to come into the clinic or hospitalto have a transfusion of red blood cells.
• You bruise easily, or, when injured, you do not stop bleeding.This could be a sign that your platelets (blood cells that help withclotting) are low. This can be serious or life-threatening. You mayneed to come into the clinic or hospital for a transfusion of platelets.
Many cancers are associated with an increased risk of blood clots forming thatcould lead to swelling in the legs and arms. These clots may travel to the lungscausing shortness of breath or to the brain causing a stroke. This may becomeserious and life threatening. Some cancer drugs can increase this risk. It isimportant to let your doctor know if you have increased shortness of breath or difficulty breathing.
Other common side effects include nausea, vomiting, and loss of appetite. Youmay also experience constipation, loose stools or diarrhea. It is important toincrease your fluid intake if diarrhea occurs. If this becomes severe, you mayhave to be hospitalized and receive intravenous fluids.
Everyone in the research study will be watched carefully for side effects. You willbe monitored during your chemotherapy to keep track of your blood counts andorgan function, particularly your kidney and liver function. If you experience side
effects, they may go away after you stop taking the study drug. Some sideeffects 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 beknown, it is important that you tell the research doctor about all prescription andnon-prescription drugs, herbal preparations and nutritional supplements that youare taking or planning to take. There may also be some foods that you shouldavoid while on this research study and your research doctor will review thisinformation 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 beeninformed of new information relating to this research study.
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[List the side effects using lay language in the categories below according to thelikelihood of occurrence.
Indicate what the side effect means for the participant (e.g., abnormal blood tests showing liver damage which is usually reversible when thedrug 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.
Please format the bullets under each risk using lay terminology. Pleaseavoid using technical medical terms unless they are the term used inspeaking 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 tobe updated. For example, instead of stating “Of the thirty individuals whohave received this drug to date, ten have experienced the following sideeffects…” please generally state: “The following side effects have beenexperienced by individuals who have received this drug:” Similarly,instead of stating “one participant experienced xyz…”, please includethese risks under the rare risks.
Please refer to the Common Risk Language Database available at theOHRS website for lay terminology: www.dfhcc.harvard.edu/ohrs and look under “New Submissions.”
If there are required interventions associated with the administration of the
study drug, then those risks should also be included. For example, if theadministration 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 themodel 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 areessential 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 ismeaningful 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.
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Additionally, if this is a dose escalation study , please include a statement suchas the following: “One risk is that you may get a dose of the study 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.”
NOTE for Phase II and III Trials: Percentages should be used to categorizerisks 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 theexact percentages are not known, then the terms likely, frequent, occasional,and rare can be used without including the associated percentage categories.You should be sure to identify those side effects that may be “serious.” Serious isdefined 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 Name] : Likely [If applicable, add: (More than a 50% chance that this willhappen) ]
• [List risks using a bulleted format with the most significant riskslisted first. Make sure that you use lay language to describe a risk.]
Frequent [If applicable, add: (Between a 10-50% chance that this willhappen) ]
• [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 willhappen) ]
• [List risks using a bulleted format with the most significant riskslisted first. Make sure that you use lay language to describe a risk.]
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Rare [If applicable, add: (Less than a 1% chance that this will happen) ]
• [List risks using a bulleted format with the most significant riskslisted first. Make sure that you use lay language to describe a risk.]
Risks Associated with Biopsies:[For studies that involve biopsy of tissue other than bone marrow, use thefollowing 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 mayinclude:
• Pain and discomfort. The amount of pain and discomfort will vary,depending on the location of the biopsy site. These risks can be discussedwith 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 canbe life threatening. As with any interventional procedure, other potentially seriouscomplications from bleeding or organ damage may occur. These might requireadditional surgical intervention.
Risks Associated with Radiological Scans and X-Rays:[For radiation risks that are greater than standard risks, provide appropriatelanguage. This language will be reviewed by the appropriate RadiationSafety Offices.] While you are in this research study, CT scans, PET/CTscans, Bone Scans, x-rays, mammograms, and/or other scans utilizingradioactivity [Include only those scans/x-rays that are applicable.] may beused to evaluate your disease. [If scans are for research purposes state:The frequency of these exams is slightly greater than what you wouldreceive as standard care. But if scans are NOT for research purposesstate: The frequency of these exams is the same as what you wouldreceive as standard care. ] In the long term, over many years, there is a
very low risk of developing a new cancer as a result of the radiologicalevaluation and treatment for your cancer. [Include if appropriate:] Certain types of drugs or combinations of these drugs with radiation mayfurther slightly increase the risk of developing a new cancer. This risk isdescribed above, in the section about the risks associated with [study drug(s)] .
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[Include only if appropriate:] There is a small risk with using the contrast agentthat is injected into a vein during the scan. It may worsen kidney function inpeople who already have decreased kidney function. Therefore, we will monitor
your kidney function closely while you participate in this study. If there is anychange 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.
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 thislanguage 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 thanwhat you would receive as standard care. But if scans are NOT for research purposes state: The frequency of these exams is about thesame as what you would receive as standard care. ] There is thought tobe a low but increased risk of cancers associated with radiation in thelong 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 abnormalmammogram, this could result in your needing a breast biopsy you would nototherwise get. An abnormal mammogram may cause you to feel upset, worried,or depressed. If you are upset, you may speak with your doctor or ask to bereferred for additional emotional support.
Risks Associated with MRI Scans:When having an MRI (Magnetic Resonance Imaging) scan, you will lie still on atable that slides into a tunnel slightly wider than your body. People who feel
uncomfortable in confined spaces (claustrophobia) may feel uncomfortable in thenarrow cylinder. If you feel uncomfortable in confined spaces, please tell your doctor. Your doctor may give you a medication to make you feel morecomfortable. As images are taken, a loud banging noise will be produced.Earplugs or headphones will be available if needed. The MRI can be stopped atany time at your request, but the scan may not be complete.
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[Include only if appropriate:] There is a small risk with using the contrast agentthat is injected into a vein during the scan. It may 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 anychange 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, you should not become pregnant[delete for studies with only male participants] or father a baby [delete for studieswith only female participants] , and should not nurse a baby [delete for studieswith only male participants] . Let your doctor know immediately if you becomepregnant or find out that you are going to be the father of a child. We canprovide counseling about preventing pregnancy for either male or female studyparticipants.
[For certain agents, such as thalidomide and related compounds, additional risksshould be included as appropriate. Additionally, if the sponsor intends to collect information on a pregnant partner, the pregnancy or the delivery outcome, this
collection of information is human subject research and the pregnant partner is aresearch participant. Accordingly, a separate informed consent document should be provided to obtain informed consent from the pregnant partner.]
Non-Physical Risks:[Include if appropriate:] Because of side effects or the time required for tests andclinic visits while you are on this research study, you may be unable to keep upwith 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.
G. WHAT ARE THE BENEFITS OF THE RESEARCH STUDY?
Taking part in this research study may or may not make your health better. Wehope the information learned from this research study will help doctors learn
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more about ____ [study drug/procedure, etc.] as a treatment for ____ [enter typeof cancer] 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 thisform, 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 tostop. Leaving the research study will not affect your medical care outside of theresearch 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 notcause any penalty or loss of benefits to which you are otherwise entitled. [NOTE for Cooperative Group Trials: Highly recommend presenting this paragraph asset forth in the model consent document.]
It is important to tell the research doctor if you are thinking about stopping soyour research doctor can evaluate the risks from stopping the ____ [drug
/combination of drugs / intervention]. In some cases, the abrupt stopping of adrug can have risks in itself. Another reason to tell your research doctor that youare thinking about stopping is to discuss what follow-up care and testing could bemost 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 thisstudy. If they will receive payment, please describe. Please note that this sectionshould not be used to describe compensation for research related injuries whichis covered later in this consent form.
When the research might lead to a medical discovery that could result in thecommercial 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, hospital, and researchers may benefit if this happens. There are no plans to pay you if your samples are used for thispurpose. ]
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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. Pleasedo 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 this applies to your study, add this statement:] You or your insurance companywill be charged for portions of your care during this research study that areconsidered standard care, [if applicable, add “including the following study drugs….”] . You may be responsible for co-payments and deductibles that aretypical for your insurance coverage.
[For drugs that are commercially available, but used off label , please includethe 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 theFDA has approved it for use in patients with another type of cancer. Becausethere 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 berequired to pay for, please call financial services for information. The contactinformation for financial services are: [include only the relevant institutional numbers]
• Dana-Farber Cancer Institute: (617) 632-3455
• Massachusetts General Hospital: (617) 726-2191
• Brigham and Women’s Hospital: (617) 732-5524 or (617) 732-7485
• Beth Israel Deaconess Medical Center: (617) 667-5661
• Children’s Hospital, Patient Care Coordination Center: (617) 355-7188
• [Add satellites and affiliate institutions under the DFCI IRB, asappropriate.]
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The National Cancer Institute provides an online resource to help peopleparticipating in cancer clinical trials understand which services their insurancecompany is required by law to pay. This can be found at the website below or
K. WHAT HAPPENS IF I AM INJURED OR SICK BECAUSE I TOOK PART IN THIS RESEARCH STUDY?
[Include only what applies to the study. If there is sponsor-specific injury language to include, please include it, but avoid redundancy and do not includeany exculpatory language, i.e., language that suggests to participants that they are giving up rights or benefits.
Institutional Names** Note that DF/HCC is not a legal entity. Accordingly, please use the following table to appropriately identify the institution(s) name to be inserted in the blank below:
We will offer you the care needed to treat injuries directly resulting from takingpart in this research. We may bill your insurance company or other third parties,if appropriate, for the costs of the care you get for the injury, but you may also beresponsible for some of them.
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Supported by Grant Supported by Industry
Researchinvolving Adultsat DFCI, MGH,BWH, BIDMC
List the institution as:
“Dana-Farber Cancer Institute (DFCI)”
“Massach
usetts General Hospital (MGH)” “Brigham
& Women’s Hospital (BWH)”
“BethIsrael Deaconess Medical Center (BIDMC)”
List the institution as:
“Dana-Farber/Partners CancerCare(DF/PCC) on behalf of the Dana-
There are no plans for __________ [insert appropriate DF/HCC ** institutionname here as described in table above, as well as sponsor name if applicable] topay you or give you other compensation for the injury. You do not give up your
legal rights by signing this form.
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. Theresearch doctor’s name and phone number are listed in this consent form.
L. WHAT ABOUT CONFIDENTIALITY?
We will take measures to protect the privacy and security of all your personalinformation, but we cannot guarantee complete confidentiality of study data.
[If medical information will become part of the hospital medical record includethen add this statement:] Medical information created by this research study maybecome part of your hospital medical record. Information that does not becomepart of your medical record will be stored in your study file. [If this is a clinical trial where participants are registered with QACT then add this statement:] It mayalso become part of a DF/HCC research database.
[When applicable add:] The results of this research study may be published. Youwill not be identified in publications without your permission.
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 removeduplicative information.]
This research study is being conducted by ____ [add name of organizationobtaining the certificate] . To help protect your privacy, ____ [add name of organization obtaining the certificate] has obtained a Confidentiality Certificatefrom 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 thatmay identify you in federal, state, or local civil, criminal, administrative, legislativeor other proceedings. Disclosure will be necessary, however, upon request of theDepartment of Health and Human Services for audit or program evaluationpurposes.
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You should understand that a Certificate of Confidentiality does not prevent youor 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 organizationobtaining the certificate] may not use the Certificate of Confidentiality to withholdthis information. This means that you and your family must also actively protectyour 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 tocontact study staff outside normal business hours, for example:
24-hour contact: DFCI: Chris Smith, MD at (617) 632-0000 or page at (617)632-0000 beeper 40000.]
For questions about your rights as a research participant, please contact arepresentative of the Office for Human Research Studies at DFCI (617) 632-3029. This can include questions about your participation in the study, concernsabout the study, a research related injury, or if you feel/felt under pressure toenroll 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 itsaffiliated research doctors, health care providers, and physician network toprotect the privacy of information that identifies you and relates to your past,present, and future physical and mental health conditions (“protected health
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information”). If you enroll in this research study, your “protected healthinformation” will be used and shared with others as explained below.
1. What protected health information about me will be used or sharedwith others during this research?
• Existing medical 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 withothers?
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 accreditationrequirements;
• To conduct public health activities (including reporting of adverseevents or situations where you or others may be at risk of harm); and
• Other reasons may include for treatment, payment, or health careoperations. For example, some medical information produced by thisresearch study may become part of your hospital medical record becausethe information may be necessary for your medical care. (You will also begiven 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 participatingin the research will use and share your protected health information. Inaddition, other DF/HCC offices that deal with research oversight, billing or quality assurance will be able to use and share your protected healthinformation.
4. With whom outside of DF/HCC may my protected health informationbe 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 thisinformation to perform functions relating to the conduct of this researchsuch as analysis by outside laboratories on behalf of DF/HCC and its
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affiliates (for example, data storage companies, insurers, or legaladvisors).
• The sponsor(s) of the study, its subcontractors, and its agent(s): ____ [enter name of sponsor]
• Other research doctors and medical centers participating in thisresearch, if applicable
• Federal and state agencies (for example, the Department of Healthand Human Services, the Food and Drug Administration, the NationalInstitutes 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 FDAand 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]
Some who may receive your protected health information may not have tosatisfy 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 healthinformation that is being used or shared for this research will bedestroyed, because research is an ongoing process.
6. Statement of privacy rights:
• You have the right to withdraw your permission for the researchdoctors and participating DF/HCC entities to use or share your protectedhealth information. We will not be able to withdraw all the information thatalready has been used or shared with others to carry out related activitiessuch as oversight, or that is needed to ensure quality of the study. To
withdraw your permission, you must do so in writing by contacting theresearcher listed above in the section: “Whom do I contact if I havequestions about the research study?”
• You have the right to request access to your protected healthinformation that is used or shared during this research and that is relatedto your treatment or payment for your treatment, but you may access thisinformation only after the study is completed. To request this information,
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please contact the researcher listed above in the section: “Whom do Icontact if I have questions about the research study?”
P. OPTIONAL RESEARCH STUDIES:
[If there are no optional research studies or procedures, please delete thissection. If there are optional research studies or procedures, at a minimum,
please briefly describe them here and include initial or signature lines for participants to indicate their choice to agree or to decline participation.]
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[Delete this Assent Section if the research DOES NOT involve children or if theIRB has determined that assent is not required.]
Signature of participant between age of 10 and 18: The person doing thisresearch study has explained what will happen to me if I take part in thisresearch study. My signature below means that I want to be in this researchstudy. I can decide not to take part in this research study if I do not want to andnothing 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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• I have had enough time to read the consent and think aboutparticipating 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 atany time
Signature of Participant Date
or Legally Authorized Representative
Relationship of Legally Authorized Representative to Participant
[Delete the second signature line below if the research DOES NOT involvechildren or if the IRB has determined that the signature of one legally authorized representative (e.g., parent) is sufficient.]
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 atany time
Signature of Legally Authorized Representative Date
Relationship of Legally Authorized Representative to Participant
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A copy of this signed consent form will be given to the participant or legallyauthorized representative, or, where the participant is a minor, the participant’sparent or legal guardian.
For Adult Participants
The participant is an adult and provided consent to participate.
Participant is a non-English speaker and signed the translated Short Form in lieuof English consent document
As someone who understands both English and the language spoken by theparticipant, I interpreted, in the participant’s language, the researcher’spresentation of the English consent form. The participant was given theopportunity to ask questions.
Signature of Interpreter:
Printed name of Interpreter:
Date:
The participant is an adult who lacks capacity to provide consent and his/her legallyauthorized representative:
gave permission for the adult participant to participate
did not give permission for the adult participant to participateor
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The parent or legally authorized representative gave permission for the minor to
participate.Parent or legally authorized representative is a non-English speaker and signedthe translated Short Form in lieu of English consent document
As someone who understands both English and the language spoken by theparticipant, I interpreted, in the participant’s language, the researcher’spresentation of the English consent form. The participant was given theopportunity to ask questions.
Signature of Interpreter:
Printed name of Interpreter:
Date:
The parent or legally authorized representative did not give permission for the minor to participate
[Delete the lines above relating to minor participants if the research involves adults only.]
Signature of Individual obtaining consent:
Printed name of above:
Date:
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