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DF/HCC Consent Local Context Language for Studies Relying on an External sIRB

This document contains consent local context language required to be inserted into the External sIRB approved consent template document at the end of the model consent document, before the signature line.

• DF/HCC consent local context language may not be changed.

• Instructions are provided in blue text and should be removed from the final version of the consent

• Prior to submission to OHRS please format the font type and size for consistence

OHRS will add the following administrative header and footer when the consent document is posted to OncPro.

Research Consent Form for External Reviewed Research

Dana-Farber/ Harvard Cancer Center

BIDMC/BCH/BWH/DFCI/MGH OHRS 10.04.2018

|DFCI Protocol Number: |Acknowledged Date by DFCI IRB: |

|Date Posted for Use: |Expiration Date (Invalid for use on or after): |

|Version Date (OnCore): |Content Last Revised with OHRS Review:  |

[Please add the following box listing the DF/HCC PI and Site PI to Page 1, following the study title.]

DF/HCC Principal Research Doctor / Institution:

DF/HCC SITE-RESPONSIBLE RESEARCH DOCTOR(S) / INSTITUTION(S):

Local Institution Information:

The following is information specific to the local Dana-Farber/Harvard Cancer Center (DF/HCC) institutions.

[If ICOI disclosure language has been mandated by the Office for Research Integrity (ORI), please inserted here]

[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

[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 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.

• 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.

DF/HCC Financial Information

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

• Brigham and Women’s Hospital/Faulkner Hospital: (617) 632-3455

• 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

• Dana-Farber Cancer Institute at Steward St. Elizabeth’s Medical Center: (800) 664-3884

• Massachusetts General Hospital/North Shore Cancer

Center: (978) 882-6319

• Massachusetts General Hospital at Newton Wellesley Hospital (617) 243-6392

• The Lawrence. & Memorial Cancer Center in affiliation with Dana-Farber Community Cancer Care: (860) 442-0711 ext. 4702

• Cape Cod Healthcare: (508) 862-7575

• New Hampshire Oncology-Hematology, P.A.: (603) 622-6484

DF/HCC Injury Language

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.

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 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.

____________________________________ __________________

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 ____ [Please enter the age, under which the external IRB has determined that assent is not required] ]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.

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:

Parent or legally authorized representative is illiterate

The consent form was read to the parent or legally authorized representative

who was given the opportunity to ask questions.

Signature of Witness:

Printed Name of Witness:

Date:

The parent or legally authorized representative did not give permission for the minor to participate

[Delete this box if the research involves adults only.]

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