PROTOCOL TITLE: Type over this box - DF/ Web viewDFCI Protocol Number:TBD. Approved Date ... the word “you” refers to your ... can include questions about your potential participation

Research Consent Form for Screening ProceduresDana-Farber/ Harvard Cancer CenterBIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS Version: 10.02.2017

Protocol Title:

[If required by the sponsor you may add the Sponsor Protocol Number here:] [Sponsor Protocol Number: (protocol number)]

DF/HCC Principal Research Doctor / Institution:

DF/HCC Site-Responsible Research Doctor(s) / Institution(s): [Here identify the specific site and the research doctor responsible at that site. If there are none, delete this line.]

Consent to Participate in Screening Procedures If you are a parent or guardian of a child under 18 years old, the word “you” refers to your child. You, the parent, will be asked to read and sign this document to give permission for your child to participate. [Delete this paragraph if the study involves adults only.]

A. INTRODUCTION

The purpose of this screening consent document is to obtain your consent to undergo certain screening procedures in order to determine whether you are eligible for participation in a research study at the Dana-Farber/Harvard Cancer Center.

The screening procedures we will ask you to undergo are not procedures required for your clinical care. They are procedures (for example, providing blood, tissue, urine) that are necessary in order to determine whether you meet the requirements for participation in a research study that might be appropriate to your condition. The specific procedures will be described below.

In order to undergo the screening tests, please read and sign this consent form which indicates that you have been told why the screening procedures are being done and the risks of each procedure.

The decision to participate is yours. You do not have to agree to participate in screening procedures or any research protocol.

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DFCI Protocol Number: TBD Approved Date (DFCI IRB Approval): TBD

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

OnCore Version Date: TBD Content Last Revised with OHRS Review: TBD


Your care at any of the DF/HCC hospitals will not be impacted if you decide not to undergo these screening procedures. It would mean, however, that certain research studies might not be available to you.

If you decide to participate, please sign and date at the end of this form. We will give you a copy of this form. If you choose not to undergo the screening procedures, your doctor will discuss with you in more detail other options available to you.

We encourage you to take some time to think this over, to discuss it with other people and to ask questions now and at any time in the future.

B. WHY ARE YOU BEING ASKED TO UNDERGO SCREENING PROCEDURES?

[Describe the main study including rationale for why it is being done. Please see Section B of the Consent Template for Biomedical Research for guidance and specific language.]

The results of your screening procedures will tell us whether you are eligible for this study. If you are eligible, the investigator will go over a separate research informed consent document that relates to that research study in particular.

C. WHAT OTHER OPTIONS ARE THERE?

Taking part in the screening procedures is voluntary. You may choose to not go through screening procedures or you may choose to start them and then withdraw during the procedures.

Please talk to the research doctor about your options before you decide whether you will undergo the screening procedures.

D. WHAT IS INVOLVED IN THE SCREENING PROCEDURES AND WHAT ARE THE RISKS?

Required Screening Procedures:Page 2 of 15





[List all screening procedures and risks, 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 on with

your usual activities. An assessment of your tumor by one or more of the following standard

assessment tools: X-ray, CT (Computerized Tomography) scan, MRI (Magnetic Resonance Imaging) or PET (Positron Emission Tomography) scans

Blood tests Urine test Biopsy Archival tissue: The research doctor will be given access to samples of

your tissue which were previously collected and stored (for example, from previous surgeries or biopsies).Your doctor will review with you whether there is enough tissue to have this screening test performed.

[add additional tests, as appropriate]

[Describe any risks of procedures here.]

There is a small risk that someone may get access to your private health information from the screening procedures, [include if applicable: including the use of archival tissue,] but we try to reduce this risk by putting into place procedures that limit access to your information.

After the screening procedures are completed:

If you do not meet the eligibility criteria, you will not be able to participate in this research study.

If you are eligible for the research study, you will receive a separate informed consent form to inform you in detail about the research study itself and all procedures involved. If you then voluntarily agree to participate in the research study, you will be asked to sign the separate informed consent form for that study.

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E. HOW MUCH TIME WILL THE SCREENING PROCEDURES TAKE?

You will be considered to be participating in the screening procedures phase for as long as it takes to do the procedures and obtain the results. It is expected that this will take approximately XX days/weeks.

F. WHAT WILL BE DONE WITH THE DATA FROM MY SCREENING TESTS?

[Please explain whether the data will be kept with this study, be discarded or be kept for future research pursuant to another protocol. If the data will be retained, the participant must specifically consent to participate in the research protocol that provides for retention of the data. ]

G. WHAT ARE THE BENEFITS OF THE SCREENING PROCEDURES?

The benefit in participating in the screening procedures is that we can tell whether you might be eligible to participate in a research study.

H. CAN I STOP PARTICIPATING IN THE SCREENING PROCEDURES AND WHAT ARE MY RIGHTS?

You have the right to choose not to sign this form. If you decide not to sign this form, you cannot participate in research studies relating to your condition where these screening procedures are required.

You can stop participating in the screening procedures at any time.

If you choose not to participate, are not eligible to participate, or change your mind about doing the screening, this will not affect your present or future care and will not cause any penalty or loss of benefits to which you are otherwise entitled.

[Include if applicable:]If you choose not to participate and the testing of the tissue has not yet been performed, the sample will be sent back to the place where it originated. Please be aware that samples will most likely be tested soon after they are received.

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I. WHAT ARE THE COSTS?

There are no costs to you to undergo screening procedures.

If you have questions about your insurance coverage, or the items you might be required to pay for, please call financial services for information. The contact information for financial services are

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/New Hampshire Oncology-Hematology: (603) 552-9106 Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford

Regional Medical Center: (508) 422-2970 Dana-Farber Cancer Institute at Steward St. Elizabeth’s Medical Center:

(800) 664-3884 Massachusetts General Hospital/North Shore Cancer

Center: (978) 882-6319 Massachusetts General Hospital at Emerson Hospital - Bethke: (978) 287-

3043 or (978) 287-3064 The Lawrence. & Memorial Cancer Center in affiliation with Dana-Farber

Community Cancer Care: (860) 442-0711 ext. 4702 Cape Cod Healthcare: (508) 862-7575 Lowell General Hospital: (978) 937-6600 Newton Wellesley Hospital: (617) 243-6392 New Hampshire Oncology-Hematology, P.A.: (603) 622-6484

The National Cancer Institute provides an online resource to help people participating in cancer clinical trials understand which services their insurance company is required by law to pay. This can be found at the website below or can be provided by the study team:

www.cancer.gov or 1-800-4-CANCER

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http://www.cancer.gov/


J. WHAT HAPPENS IF I AM INJURED OR BECOME SICK BECAUSE I TOOK PART IN THESE SCREENING PROCEDURES?

[Include the following required language. If the sponsor requests changes, note that the IRB will not approve language that:

Attempts to define a screening-related injury (for example, by specifically excluding pre-existing conditions and underlying disease)

Attempts to impose standards of behavior on participants (for example, “Sponsor will pay your costs if you followed the study team directions”)

Attempts to limit the amount of coverage that will be provided (for example, “Sponsor will pay your reasonable medical costs only,” or “Sponsor will not pay for lost wages”)

Includes legal or not lay-friendly terminology (for example, “Sponsor will not pay if the investigator was negligent or engaged in willful misconduct”)

Discusses the Sponsor’s obligations versus the institution’s (for example, “Sponsor will not pay if the study team did not follow the protocol”)

Appears contractual or is potentially exculpatory (for example, “You agree that Sponsor is not responsible”)]

If you think you have been injured as a result of any screening procedures, tell the doctor as soon as possible. The doctor’s name and phone number are listed in this consent form.

The treating hospital will offer you the care needed to treat injuries directly resulting from taking part in these screening procedures. These treatments will be billed to your insurance company. You will be responsible for deductibles and co-payments. There are no plans to pay you or give you other compensation for the injury. You do not give up your legal rights by signing this form.

We will need to collect certain personal information about you, such as your name, date of birth, gender, social security number or Medicare identification number and information related to this research study. We will not use this information for any other purpose.

For questions about a screening-related injury, please contact the Office for Human Research Studies at Dana-Farber Cancer Institute: (617) 632-3029.

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K. WHAT ABOUT CONFIDENTIALITY?

We will take measures to protect the privacy and security of all your personal information, but we cannot guarantee complete confidentiality of screening data.

Medical information created by participating in these screening procedures may become part of your hospital medical record. Information that does not become part of your medical record will be stored in your study file.

L. WHOM DO I CONTACT IF I HAVE QUESTIONS ABOUT THE SCREENING PROCEDURES?

If you have questions about the screening procedures, please contact your doctor or study staff as listed below:

[Add contact information for principal research doctor, research doctors and study staff as appropriate for each site – use a bulleted format.

For example:

Dana-Farber Cancer Institute Chris Smith, MD: (617) 632-0000 Pat Black, RN, NP: (617) 632-0000

Include a phone number and instructions on what to do if the participant needs to contact study staff outside normal business hours, for example:

24-hour contact: Dana-Farber Cancer Institute: Chris Smith, MD at (617) 632-0000 or page at (617) 632-0000 beeper 40000.]

For questions about your rights, please contact a representative of the Office for Human Research Studies at Dana-Farber Cancer Institute: (617) 632-3029. This can include questions about your potential participation in a study, concerns about the screening procedures, a screening- related injury, or if you feel/felt under pressure to agree to the screening procedures.

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M. PRIVACY OF PROTECTED HEALTH INFORMATION

Federal law requires Dana-Farber/Harvard Cancer Center (DF/HCC) and its affiliated research doctors, health care providers, and physician network to protect the privacy of information that identifies you and relates to your past, present, and future physical and mental health conditions (“protected health information”). If you participate in these screening procedures and sign this consent form you are allowing, your “protected health information” to be used and shared with others as explained below.

1. What protected health information about me will be used or shared with others during this screening procedure?

Existing medical records New health information created from the screening procedure results

2. Why will protected information about me be used or shared with others?

The main reasons include the following: To conduct and oversee the procedures described earlier in this form; To ensure the screening procedures meets legal, institutional, and

accreditation requirements; To conduct public health activities (including reporting of adverse events or

situations where you or others may be at risk of harm); and Other reasons may include for treatment, payment, or health care

operations. For example, some medical information produced by the screening become part of your hospital medical record because the information may be necessary for your medical care. (You will also be given a notice for use and sharing of protected health information.)

3. Who will use or share protected health information about me?

DF/HCC and its affiliated research doctors and entities participating in the screening procedures will use and share your protected health information. In addition, other DF/HCC offices that deal with research oversight, billing or quality assurance will be able to use and share your protected health information.

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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 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 all study sponsors] Other research doctors and medical

centers participating in the screening, if applicable Federal and state agencies (for example, the Department of Health and

Human Services, the Food and Drug Administration, the National Institutes of Health, and/or the Office for Human Research Protections), or other domestic or foreign government bodies and other appropriate government agencies if required by law and/or necessary for oversight purposes. A qualified representative of the FDA and the National Cancer Institute may review your medical records.

Hospital accrediting agencies 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?

The protected health information will be stored until it is determined whether or not you will participate in a research study based upon the results of the screening procedures.

6. Statement of privacy rights:

While you may withdraw from participating in the screening procedures at any time, without putting anything in writing, your right to withdraw your permission for the research doctors and participating DF/HCC entities to

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use or share your protected health information must be in writing. We will not be able to withdraw all the information that already has been used or shared with others to carry out related activities such as oversight, or that is needed to ensure quality of the screening procedures. To withdraw your permission, you must do so in writing by contacting the doctor listed above in the section: “Whom do I contact if I have questions about the screening procedures?”

You have the right to request access to your protected health information that is used or shared during this screening process and that is related to your treatment or payment for your treatment. To request this information, please contact the doctor listed above in the section: “Whom do I contact if I have questions about the screening procedures?

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N. DOCUMENTATION OF ASSENT

[Delete this Assent Section if the research DOES NOT involve children or if you expect Assent will not be required by the IRB.]

Signature of participant between age of 10 and 18: The person doing this research study has explained what will happen to me if I take part in this research study. My signature below means that I want to be in this research study. I can decide not to take part in this research study if I do not want to and nothing will happen to me if I decide I do not want to participate.

____________________________________ __________________Signature of Participant Date

To be completed by person obtaining assent:

The assent discussion was initiated on (date).

The information was presented in age-appropriate terms. The minor:

Agreed to take part in the study

Did not agree to take part in the study

An assent discussion was not initiated with the minor for the following reason(s):

Minor is incapacitated

Minor is under 10 years of age

Other

Signature of Individual obtaining assent:

Printed name of above:

Date:

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O. DOCUMENTATION OF CONSENT

My signature below indicates: I have had enough time to read the consent and think about participating

in this study; I have had all of my questions answered to my satisfaction; I am willing to participate in this study; I have been told that my participation is voluntary and I can withdraw at

any time

Signature of Participant Dateor Legally Authorized Representative

Relationship of Legally Authorized Representative to Participant

[Please include the second signature line below ONLY if the IRB has determined that a second signature is required.]

My signature below indicates: I have had enough time to read the consent and think about participating

in this study; I have had all of my questions answered to my satisfaction; I am willing to participate in this study; I have been told that my participation is voluntary and I can withdraw at

any time

Second Signature of Legally Authorized Representative Date

Relationship of Legally Authorized Representative to Participant

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Delete the following if the research involves children only:

Adult ParticipantsTo be completed by person obtaining consent:

The consent discussion was initiated on (date).

Signature of individual obtaining consent:


Date:

A copy of this signed consent form will be given to the participant or legally authorized representative.

1) The participant is an adult and provided consent to participate.

1a) Participant (or legally authorized representative) is a non-English speaker andsigned 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:

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1b) Participant is physically unable to sign the consent form because:

The participant is illiterate.

The participant has a physical disability.

Other (please describe): _________________________________________

The consent form was presented to the participant who was given the opportunity to ask questions and who communicated agreement to participate in the research.

Signature of Witness:

Printed Name of Witness:

Date:

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

Delete the following if the research involves adults only:

Minor ParticipantsTo be completed by person obtaining consent:

The consent discussion was initiated on (date).

Signature of individual obtaining consent:


Date:

A copy of this signed consent form will be given to the participant’s parent or legal guardian.

1) The parent or legally authorized representative gave permission for the minor to participate.

1a)Parent or legally authorized representative is a non-English speaker and signedthe translated Short Form in lieu of English consent document

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As someone who understands both English and the language spoken by the participant, I interpreted and/or witnessed, in the participant’s language, the researcher’s presentation of the English consent form. The participant was given the opportunity to ask questions.

Signature of Interpreter/Witness:

Printed name of Interpreter/Witness:

Date:

1b) Parent or legally authorized representative physically unable to sign the consent form because:

The participant is illiterate.

The participant has a physical disability.

Other (please describe): _________________________________________

The consent form was presented to the participant who was given the opportunity to ask questions and who communicated agreement to participate in the research.

Signature of Witness: __________________________________________________

Printed Name of Witness:

Date:

1c) The parent or legally authorized representative did not give permission for the minor to participate

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Documents

PROTOCOL TITLE: Type over this box - DF/ Web viewDFCI Protocol Number:TBD. Approved Date ... the word “you” refers to your ... can include questions about your potential participation