National Cancer Institute
Central IRB Initiative
CIRB Operations Office
c/o: The EMMES Corporation
401 N. Washington St. Suite 700
Rockville, MD 20850
Tel: 1-888-657-3711 (Toll Free)
Fax: 301-560-6538
Email: [email protected]
December 11, 2015
Polly Goodman, BS
[Via Email]
Re:
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Signatory Institution: Dana-Farber Cancer Institute
Dear Ms. Goodman,
On December 11, 2015, the NCI Pediatric CIRB reviewed and approved the revised Annual Signatory
Institution Worksheet About Local Context for Dana-Farber Cancer Institute received on December 1, 2015.
The information contained in this Worksheet contributes toward establishing the Institution’s local context
considerations for the CIRB. The NCI Adult CIRB – Early Phase Emphasis, NCI Adult CIRB – Late Phase
Emphasis, and the Cancer Prevention and Control CIRB relies on the NCI Pediatric CIRB for the review of the
Annual Signatory Institution Worksheet About Local Context.
The CIRB reviewed and approved the consent form boilerplate language and institutional requirements. The
CIRB understands that no consent form text is being deleted from the CIRB-approved consent form(s).
No changes to either the boilerplate language or institutional requirements may be implemented
without prior CIRB approval. Any changes must be reported promptly to the CIRB for review and approval
prior to implementation.
The CIRB recognizes that HIPAA language has been provided as part of the boilerplate language. The CIRB
accepts this inclusion as part of the boilerplate language, but the CIRB does not function as a Privacy Board.
Therefore, the CIRB is not reviewing this language for compliance with HIPAA regulations.
The CIRB-approved boilerplate language to be inserted into the CIRB-approved consent form(s) by the
Investigator is as follows:
Research Consent Form
for NCI-CIRB Reviewed Research
Dana-Farber/ Harvard Cancer Center
BIDMC/BCH/BWH/DFCI/MGH
Protocol Title:
Sponsor Protocol Number:
DF/HCC Principal Research Doctor / Institution:
OHRS 12.01.2015
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
December 11, 2015
Page 2 of 15
DF/HCC Site-Responsible Research Doctor(s)/Institution(s):
[The study title for participants may be entered here.]
INSTITUTIONAL REVIEW BOARD INFORMATION:
You have been asked whether you would be interested in participating in a research study. All
research studies conducted by the Dana-Farber/Harvard Cancer Center are typically reviewed by the
Dana-Farber Cancer Institute institutional review board with respect to the risks and benefits of
participation in the research and the protection of human subjects in research.
For this research study, the Dana-Farber Cancer Institute Institutional (DFCI) Review Board (IRB) has
agreed to rely on an outside IRB for the review and general oversight of this research study. The
name of the outside IRB is the National Cancer Institute Central Institutional Review Board (NCI
CIRB).
The following is specific information relating to this study:
[Insert NCI Model Consent Document]
[THIS SECTION SHOULD BE ADDED TO THE END OF THE HOW LONG WILL I BE IN THIS STUDY SECTION OF THE MODEL
CONSENT]
[Include only if appropriate:]
Storage of Stem Cells:
At times more cells are collected from a donation than are needed to do the transplantation. If your physician
determines that it is preferable to administer a dose of cells that is less than the complete collection, the extra
cells may be frozen and stored in our freezers for your future use. After 10 years, the laboratory will discard
any remaining stored cells if your doctor determines that they are no longer clinically useful to you.
Alternatively, if your donor is related to you, you may request in writing that we transfer these frozen cellular
products to another facility of your choice. If your donor is unrelated to you, these remaining cells will be
discarded
[THIS SECTION SHOULD BE ADDED TO THE END OF THE RISK SECTION OF THE MODEL
CONSENT]DF/HCC RADIATION RISK INFORMATION
[Include the following paragraph if the study involves research scans or x-rays.] Cancer research often
includes, 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.
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
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
December 11, 2015
Page 3 of 15
evaluate your disease. The frequency of these exams is slightly greater than what you would receive
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 radiological evaluation and treatment for your cancer. [Include if
appropriate:] 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 XRays.”] 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.
[Include only if appropriate:]
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.
[Include only if appropriate:]
Risks Associated with Leukapheresis Collection:
We will collect some of your blood cells in a procedure called “leukapheresis”. You will have IVs inserted, one
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
December 11, 2015
Page 4 of 15
in each arm. If a special central venous catheter is needed, that will be discussed separately by your research
team. The blood is taken out of one arm and run through a machine that collects only the cells we want. The
rest of your blood is given back to you in the other arm. The whole collection process takes up to7 hours,
depending on how many cells are needed.
.
Risks of Procedure
You may experience the side effects listed below while undergoing the collection of white blood cells.
These reactions or side effects are usually reversible when the procedure is stopped or with the
correct medical care.
• A sterile anticoagulant solution is used to prevent your blood from clotting in the machine. The
anticoagulant works by binding to calcium in your blood. You may experience tingling of your lips or
fingers, a “vibrating” sensation, or more rarely, nausea, vomiting or muscle tightness. To counteract
these possible symptoms, we give replacement calcium to you by vein during the procedure. If
these symptoms occur despite replacement calcium, more calcium will be given until symptoms
resolve.
• You will receive about 1 to 2 quarts of anticoagulant solution by vein during each collection
procedure. If you have a history of heart failure or kidney disease, you may retain some of this fluid,
causing increased weight or swelling in your hands or feet. A large volume of extra fluid may cause
shortness of breath. These symptoms can be treated with diuretics.
• The anticoagulant solution contains dextrose (sugar). If you have diabetes, you may require extra
insulin to keep your blood sugar level within the desired range.
• Low blood pressure, high blood pressure or slow pulse may occur as a result of blood being moved
through the machine. If these occur, the procedure will be slowed or stopped until symptoms
resolve.
• Blood pressure medicines called Angiotensin Converting Enzyme (ACE) inhibitors should not be
taken before your collection procedure. These medications may cause low blood pressure during
your collection procedure. If you are on an ACE inhibitor, your physician may prescribe an alternate
blood pressure medication.
• Some blood platelets (cells in the blood involved in clotting) are removed during stem cell collection.
If your platelet counts drop very low, you may need to receive a platelet transfusion to prevent
bleeding.
• Your red cells and plasma may not be returned to you if there are any problems with needle
placement in your veins or with the apheresis equipment. A decreased red blood cell count may
occur as a result. However your counts should return to normal within 4 weeks. If your blood counts
are extremely low, you may need to receive a red cell transfusion to prevent symptoms.
• Some patients with a history of migraine can have return of their migraine headaches with therapy. If
you have a migraine history, notify your physician and you will be treated with magnesium by vein to
help prevent migraines.
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
December 11, 2015
Page 5 of 15
• Although extremely rare, serious or life-threatening reactions are possible and include allergic
reactions, infections, seizures, air embolism or arrhythmias (abnormal heart rhythms). We will
carefully monitor you for these and if they begin, we will immediately stop the procedure and treat
you accordingly.
[THIS SECTION SHOULD BE INSERTED FOLLOWING THE WHAT ARE THE COSTS SECTION OF THE MODEL
CONSENT] DF/HCC FINANCIAL INFORMATION
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
Dana-Farber Cancer Institute: (617) 632-3455
Massachusetts General Hospital: (617) 726-2191
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in clinical affiliation with South Shore
Hospital: (781) 624-4329
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center:
(508) 422-2970
Massachusetts General Hospital/North Shore Cancer
Center: (978) 882-6319
[THIS SECTION SHOULD BE INSERTED FOLLOWING THE WHAT HAPPENS IF I AM INJURED SECTION OF THE
MODEL CONSENT] DF/HCC INJURY LANGUAGE
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
December 11, 2015
Page 6 of 15
[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 include any exculpatory language, i.e.,
language that suggests to participants that they are giving up rights or benefits.
The DF/HCC will offer you the care needed to treat injuries directly resulting from taking part 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 as noted earlier you may also be responsible for some of them.
[THIS SECTION SHOULD BE INSERTED AFTER THE WHO CAN ANSWER QUESTIONS ABOUT THE STUDY
SECTION OF THE MODEL CONSENT] DF/HCC 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 for the purpose of this or other research relating the study drug and
its use in cancer; and,
 Other reasons may include for treatment, payment, or health care operations. For example, some
medical information produced by this 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
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
December 11, 2015
Page 7 of 15
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, and its agent(s): ____ [enter name of sponsor]
Other research doctors and medical centers participating in this research, including: [enter
name(s) of other research doctors and/or medical centers]
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]
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: “DF/HCC Investigator Contact
Information”
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: “DF/HCC Investigator Contact
Information”
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 providing assent: 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.
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
____________________________________
Signature of Participant
December 11, 2015
Page 8 of 15
__________________
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 ____ years of age
Other
Signature of Individual obtaining assent:
Printed name of above:
Date:
Adult Participants
To be completed by person obtaining consent:
The consent discussion was initiated on
(date).
Signature of individual obtaining consent:
Printed name of above:
Date:
A copy of this signed consent form will be given to the participant or legally authorized representative, or, where the
participant is a minor, the participant’s parent or legal guardian.
For Adult Participants
1) The participant is an adult and provided consent to participate.
1a) Participant (or legally authorized representative) is a non-English speaker and
signed the translated Short Form in lieu of English consent document:
As someone who understands both English and the language spoken by the participant, I interpreted and/or
witnessed, in the participant’s language, the researcher’s presentation of the English consent form. The participant
was given the opportunity to ask questions.
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
December 11, 2015
Page 9 of 15
Signature of Interpreter/Witness:
Printed Name of Interpreter/Witness:
Date:
1b) Participant is illiterate
The consent form was read to the participant who was given the opportunity
to ask questions.
Signature of Witness:
Printed Name of Witness:
Date:
2) The participant is an adult who lacks capacity to provide consent and his/her legally authorized representative:
2a) gave permission for the adult participant to participate
2b) did not give permission for the adult participant to participate
Minor Participants
To be completed by person obtaining consent:
The consent discussion was initiated on
(date).
Signature of individual obtaining consent:
Printed name of above:
Date:
A copy of this signed consent form will be given to the participant or legally authorized representative, or, where the
participant is a minor, the participant’s parent or legal guardian.
The parent or legally authorized representative gave permission for the minor to participate.
Parent or legally authorized representative is a non-English speaker and signed
the translated Short Form in lieu of English consent document
As someone who understands both English and the language spoken by the participant, I interpreted and/or
witnessed, in the participant’s language, the researcher’s presentation of the English consent form. The
participant was given the opportunity to ask questions.
Signature of Interpreter/Witness:
Printed name of Interpreter/Witness:
Date:
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
December 11, 2015
Page 10 of 15
Parent or legally authorized representative is illiterate
The consent form was read to the parent or legally authorized representative
who was given the opportunity to ask questions.
Signature of Witness:
Printed Name of Witness:
Date:
The parent or legally authorized representative did not give permission for the minor to participate
[Delete this box if the research involves adults only.]
Page 10 of x
DFCI Protocol Number:
DFCI IRB acknowledged on: _____
Date Posted for Use:
Date External IRB Approval Expires:
OnCore Version Date:
Content Last Revised with OHRS Review:
The translation of the CIRB-approved boilerplate language to be inserted into the CIRB-approved
consent form(s) by the Investigator is as follows:
 None Provided
The CIRB agrees that Investigators conducting CIRB-approved studies must comply with the
institutional requirements as follows:
 Our institution also allows for the use of Consent Short Forms for non-English speaking subjects. All
short forms include an addendum as well to document a subject’s consent to any optional studies.
o English Short Forms translated in the following languages: Tagalog, Hebrew, Armenian,
Albanian, Amharic, Arabic, Bengali, Brazilian, Bulgarian, Cambodian, European, Greek, Haitian,
Hindi, Italian, Japanese, Korean, Nepali, Polish, Russian, Serbo-Croatian, Simplified Chinese,
Spanish, Thai, Turkish, Vietnamese
Short Form Consent to Participate in a Research Study
Dana-Farber/ Harvard Cancer Center (DF/HCC)
BIDMC/BWH/BCH/DFCI/MGH/Network Affiliates
version: XX/XX/XX
Protocol Number:
Principal Investigator Name: _______________________________________
Consenting Investigator Name: _____________________________________
The use of “you” throughout this document refers to the research participant. It also refers to the person
authorized to give consent for the subject’s participation in this research study.
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
December 11, 2015
Page 11 of 15
Consent to Participate in a Research Study
You are being asked to participate in a research study. Please take your time to make your decision and
discuss it with your family and friends.
Before you agree to participate, the investigator must tell you:
1)
2)
3)
4)
5)
The purposes, procedures, and duration of the research;
Any procedures which are experimental;
Any reasonably foreseeable risks, discomforts, and benefits of the research;
Any potentially beneficial alternative procedures or treatments; and,
How confidentiality will be maintained and how your health information will be protected.
Where applicable, the investigator must also tell you about:
1)
2)
3)
4)
5)
6)
7)
8)
Any available compensation or medical treatment if injury occurs;
The possibility of unforeseeable risks;
Circumstances when the investigator may stop your participation;
Any added costs to you;
What happens if you decide to stop participating;
When you will be told about new findings that may affect your willingness to participate;
How many people will be in the study; and,
For clinical trials: A description of this clinical trial will be available at www.ClinicalTrials.gov, as required by
U.S. Law. The 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 the Web site at any time.
If you agree to participate, you will be given a signed copy of this document and a copy of the English
language consent form for the study.
You may contact
about the study or a research-related injury.
at
any time you have questions
You may also contact Dana-Farber Cancer Institute’s Institutional Review Board at telephone number (617)
632-3029 if you have questions about your rights as a research subject.
Your participation in this research study is voluntary, and you will not be penalized or lose any benefits if you
refuse to participate or decide to stop.
Signing this document means that the research study, including the above information, has been described to
you orally, and that you voluntarily agree to participate:
____________________________________
Signature of Participant
Or Legally Authorized Representative
_____________
Date
__________________________________________________________
Relationship of the Legally Authorized Representative to the Participant
____________________________________
Signature of Interpreter/Witness
_____________
Date
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
o
December 11, 2015
Page 12 of 15
English Addendum to Short Form translated in the following languages: Hebrew, Armenian,
Albanian, Amharic, Arabic, Bengali, Brazilian, Bulgarian, Cambodian, European, Greek, Haitian,
Hindi, Italian, Japanese, Korean, Nepali, Polish, Russian, Serbo-Croatian, Simplified Chinese,
Spanish, Thai, Turkish, Vietnamese
Addendum to the Short Form Consent to Participate in a Research Study
Dana-Farber/ Harvard Cancer Center (DF/HCC)
BIDMC/BWH/BCH/DFCI/MGH/Network Affiliates
version: XX/XX/XXXX
Protocol Number: _______________________
Principal Investigator Name: _____________________________________
Consenting Investigator Name: ___________________________________
The use of “you” throughout this document refers to the research participant. It also refers to the person
authorized to give consent for the subject’s participation in this research study.
Addendum for Optional Studies
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 your family and friends.
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.
Please indicate whether or not you want to take part in the optional research studies.
Optional Study #1:
 Not applicable
 Yes
Initials
________ Date
 No
Initials
________ Date
 Yes
Initials
________ Date
 No
Initials
________ Date
 Yes
Initials
________ Date
 No
Initials
________ Date
Optional Study #2:
 Not applicable
Optional Study #3:
 Not applicable
Optional Study #4:
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
 Not applicable
 Yes
Initials
________ Date
Initials
________ Date
 Yes
Initials
________ Date
 No
Initials
________ Date
 Yes
Initials
________ Date
 No
Initials
________ Date
 Yes
Initials
________ Date
 No
Initials
________ Date
 Yes
Initials
________ Date
 No
Initials
________ Date
 Yes
Initials
________ Date
 No
Initials
________ Date
 Yes
Initials
________ Date
 No
Initials
________ Date
 No
Optional Study #5:
 Not applicable
Optional Study #6:
 Not applicable
Optional Study #7:
 Not applicable
Optional Study #8:
 Not applicable
Optional Study #9:
 Not applicable
Optional Study #10:
 Not applicable
__________________________________________________
Signature of Participant
Or Legally Authorized Representative
_____________
Date
__________________________________________________________________
Relationship of the Legally Authorized Representative to the Participant
December 11, 2015
Page 13 of 15
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
__________________________________________________
Signature of Interpreter/Witness
December 11, 2015
Page 14 of 15
_____________
Date
The Signatory Institution Principal Investigator has the responsibility for ensuring that CIRB-approved
boilerplate language is appropriately inserted into the CIRB-approved consent form(s) and institutional
requirements are met.
The following institutions are included in this approval and future CIRB approvals will pertain to these
institutions also, until the CIRB is notified of a change:
Component Institutions: Component Institutions are defined by the CIRB as meeting all of the following
criteria:
• the Component Institution operates under a different name than the Signatory Institution, but the
Signatory Institution has legal authority for the Component Institution;
• the FWA number for the Component Institution is the same as the Signatory Institution;
• the local context considerations of the Component Institution are the same as the Signatory
Institution. Local context considerations are reported by the Signatory Institution in the Annual
Signatory Institution Worksheet About Local Context;
• the boilerplate language and institutional requirements of the Component Institution are the same as
the Signatory Institution. The boilerplate language and institutional requirements are reported by the
Signatory Institution in the Annual Signatory Institution Worksheet About Local Context; and
• the conduct of research at the Component Institution and the Signatory Institution is monitored by the
same office.
1.
2.
3.
4.
5.
6.
7.
8.
9.
Beth Israel Deaconess Medical Center
Boston's Children's Hospital
Brigham and Women's Hospital
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional
Dana-Farber/Brigham and Women's Cancer Center at South Shore
Mass General/ North Shore Cancer Center
Massachusetts General Hospital Cancer Center
Steward Saint Elizabeth's Medical Center
The Dana-Farber Cancer Institute at Londonderry
Affiliate Institutions: Affiliate Institutions are defined by the CIRB as meeting all of the following criteria:
• the local context considerations of the Affiliate Institution are the same as the Signatory Institution.
Local context considerations are reported by the Signatory Institution in the Annual Signatory
Institution Worksheet About Local Context;
• the boilerplate language and institutional requirements of the Affiliate Institution are the same as the
Signatory Institution. The boilerplate language and institutional requirements are reported by the
Signatory Institution in the Annual Signatory Institution Worksheet About Local Context; and
• the conduct of research at the Affiliate Institution and the Signatory Institution is monitored by the
same office.
1.
2.
Cape Cod Hospital
Lawrence and Memorial Cancer Center
The CIRB reminds you that any additions or deletions to the list of Component or Affiliate Institutions included
in this letter must be reported to the CIRB in a timely manner.
CIRB Approval of the Annual Signatory Institution Worksheet About Local Context
Dana-Farber Cancer Institute
December 11, 2015
Page 15 of 15
If you have any questions regarding this review, contact the CIRB at [email protected].
Sincerely,
NCI Pediatric CIRB
cc:
Michele Russell-Einhorn
Joseph Farella, BA
Christopher Walsh
Emily Eldh, BA
Phuong Ho, BA
Jennifer Coes, BA
Susan Lemoine, BA
Mallory Matuszek, MS
Jianfei Fan, BA
Sarah Florio, BS
Nicole Hackett
Signatory Institution PIs
NCI CIRB Operations Office
NCI Adult CIRB – Late Phase Emphasis
NCI Adult CIRB – Early Phase Emphasis
NCI Cancer Prevention and Control CIRB