protocol title: type over this box - dfhcc.harvard.edu · web viewhiv tests. you will have blood...

Research Consent FormDana-Farber/ Harvard Cancer CenterBIDMC/BCH/BWH/DFCI/MGH/Partners Network Affiliates OHRS 6.17.2019

Protocol Title: Sponsor Protocol Number:

DF/HCC Principal Research Doctor / Institution:

DF/HCC Site-Responsible Research Doctor(s) / Institution(s):

Main Consent

[Delete this paragraph if the study involves adults only]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.

INTRODUCTION AND KEY INFORMATION [If the protocol uses multiple consent forms or this is not the “main” consent form, this section should be written to address the specific research for which consent is being sought, rather than generalized]All research is voluntary. It is your choice whether you take part in this research or not. If you decide to participate, please sign and date at the end of this form. We will give you a copy and you can refer to this consent form at any time.

The following is a short summary of this research study to help you decide whether you would like to be a part of this study. More detailed information is provided later in this form. For purposes of this research, you will be referred to as a “participant.”

1. Why am I being invited to take part in a research study?[Include the following statement and edit as appropriate] You are invited to take part in in this research study, because you have ____.

2. Why is this research being done? [Tell the subject the purpose/ objective of the research in a brief statement].

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

Date Posted for Use: TBD

OHRS, 06/19/18,

[Insert protocol title]

OHRS, 01/09/18,

[State the general disease to be studied, for example: colon cancer. Describe specifically the type/stage/presentation of the disease being studied here. For example: “Colon cancer that has spread and has not responded to standard treatment.”]

OHRS, 05/23/18,

This new requirement emphasizes the importance of presenting the information that would be most important to a subject (or a legally authorized representative) before presenting other information. In general, our expectation is that this initial presentation of the key pieces of information will be relatively short. This section of the consent could, in appropriate circumstances, include a summary of relevant pieces of information that are explained in greater detail later in the consent form.In general, we would expect the beginning of an informed consent would include a concise explanation of the following: (1) the fact that consent is being sought for research and that participation is voluntary; (2) the purposes of the research, the expected duration of the prospective subject’s participation, and the procedures to be followed in the research; (3) the reasonably foreseeable risks or discomforts to the prospective subject (summarized); (4) the benefits to the prospective subject or to others that may reasonably be expected from the research; and (5) appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject.

OHRS, 01/09/18,

NOTES to Informed Consent Authors: This template contains DF/HCC required and recommended language for informed consent documents. Informed consent authors should avoid changing required and recommended text except where it is not relevant or appropriate to a specific protocol.Model text for use in the informed consent form is in black text. In most cases the black text should be retained when adapting the template to a specific protocol. However, for some types of studies, the language may not be appropriate. If you have questions about the applicability of text in this template, please contact the Office for Human Research Studies (OHRS) at (617) 632-3029.Instructions and examples for informed consent authors are in [brackets and italics]. A blank line, ______, is used where the information to be inserted is clear. 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).COMBINATION PHASE STUDIES (e.g. Phase I/II): Generally, the IRB will review separate consent forms for each phase of the study. Only the consent form for the phase that is open needs be submitted. For instance, please only submit the Phase I consent with the New Project Application, and then submit the Phase II consent with an Amendment when that phase is opening. Please contact OHRS if both the Phase I and Phase II portions will be open to enrollment concurrently.Please do not use the word “treatment” when referring to the “study drug.” Please use “study drug,” “study agent,” “study drug administration,” etc. as appropriate.OPTIONAL STUDIES: Whenever possible, the IRB prefers that the optional studies be incorporated into the main consent under a separate section, rather than in a separate document. Each optional studies section should include a separate section for the participant’s initials and the date. This initial/signature section should be placed after the privacy section and before the assent/consent documentation sections. TISSUE COLLECTIONS/OWNERSHIP: If the protocol involves the collection of 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 the tissue might remain at the DF/HCC or might be transferred to another institution.”SHARING TISSUE/DATA WITH COMMERCIAL ENTITIES: When sending the data or tissue with commercial entities, please make sure that the protocol states with whom identified and de-identified information will be shared.

OHRS, 06/19/18,

[Descriptor If there is more than one consent form used for this protocol, insert a descriptor here, e.g., Consent for Optional Biopsies, or Consent for Phase II, etc. Please then describe below only what applies to the part of the study that is described here]

OHRS, 01/09/18,

[Identify the specific site and the research doctor responsible at that site. If there are none, delete this line.]

OHRS, 06/19/18,

[Identify the principal investigator and corresponding site.]

OHRS, 01/09/18,

If required by the sponsor, you may add the Sponsor Protocol Number here (the sponsor protocol number may not be placed anywhere else on this document.


3. Who is supporting this research?

_____ is supporting this research study by providing ____.

4. What does this research study involve and how long will it last?[Provide a brief overview of what the study entails along with the study procedures, and the duration of the research. Please follow the prompts below and add/edit/delete as applicable.]This research study involves ____.

[Include the following paragraph when appropriate and add/delete/edit as needed] The names of the study [intervention/research activity] involved in this study are/is:

Questionnaires Data Collection Sample Collection

The research study procedures include [include the following and revise as appropriate: screening for eligibility and study interventions including evaluations and follow up visits.]

You will be in this research study for up to_______.

It is expected that about ____ people will take part in this research study.

Information about you and your health is personal and private. Generally, it cannot be obtained without your written permission. By signing this form, you are providing that permission and your information may be obtained and used in accordance with this informed consent and as required or allowed by law. This means that researchers may obtain information regarding your past medical history, as well as specimens and samples from previous health care providers such as hospitals and labs.

5. What are the risks to participating in this study?[Include the information below. The risks should address any potential loss of privacy/ emotional distress].There are risks to taking part in any research study. We want to make sure you know about a few key risks right now. More detailed information is provided in the “What are the risks or discomforts of the research study?” section

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OHRS, 01/09/18,

[state the total number at all participating centers]

OHRS, 01/09/18,

[estimated length of time]

OHRS, 01/09/18,

[State the primary study [drug/device/intervention] modality, for example: chemotherapy, surgical [drug/device/intervention], targeted therapy, etc. This may also include a social and behavioral research activity. Please edit as appropriate for the research study.]

OHRS, 01/09/18,

[funding for the research study, the study drug, study procedures, etc.]

OHRS, 01/09/18,

[name of sponsor or supporter; please also briefly define the sponsor, e.g., “XXX, a pharmaceutical company,”]


Major known risks to participating in this research study include: [e.g. Disclosure of sensitive personal information may result is a loss of

privacy Possible emotional distress due to personal questions Significant amount of time required to complete questionnaires (online

and/or in person) Significant amount of time required to attend study visits]

6. Will being in this study benefit me in any way?

We do not know if taking part in this study will benefit you. This study may help researchers learn information that could help people in the future.

7. What are my options?

Instead of being in this research study, you have other options which may include the following: [include in bulleted format only those items that are appropriate]

Decide not to participate in this research study Participate in another research study.

[NOTE for Cooperative Group Trials: It is strongly recommended that this paragraph be presented as set forth in the model consent document.]If you choose not to participate, are not eligible to participate, or withdraw from this research study, this will not affect your present or future care and will not cause any penalty or loss of benefits to which you are otherwise entitled.

We encourage you to take some time to think this over, to discuss it with other people and your primary doctor, and to ask questions at any time.

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OHRS, 01/09/18,

If there are other options relevant for this patient population, please add them as applicable (i.e. if the protocol involves grief counseling, receive grief counseling outside of a research study).


A. WHY IS THIS RESEARCH STUDY BEING DONE?

[If this is a Pilot Study, include the following:]This research study is a Pilot Study, which is the first-time investigators are examining this _____.

[If this is a Feasibility Study, include the following:]This research study is a Feasibility Study, which is the first-time investigators are examining this _____.

[Please explain in lay language why this study is being done and what you hope to learn from the research, include the following information in bulleted format]In this research study, we are:

What is the name of the [intervention] that is being studied; How was the [intervention] developed; How is the [intervention] expected to work; Specify whether the [intervention] been used for another disease, or if it

has only been tested in other social or behavioral experiments; Explain what information was learned from any prior uses / investigations; Describe what you are hoping to learn in this research.

B. WHAT IS INVOLVED IN THE RESEARCH STUDY?

Before the research starts: After signing this consent form, you will be asked to answer some questions or undergo some screening tests or procedures to find out if you can be in the research study. [List all screening tests and procedures, using a bulleted format. Define all procedures/ assessments at the initial reference and just list the procedure at subsequent references. Please add/edit/delete the bullets below for the study as applicable]

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.

A psychological screening, which includes questions about your emotions, your thoughts, and your feelings.

Biobanking: Biological specimens (such as blood, tissue, or saliva) will be collected and shared with an outside lab or collaborator for analysis.

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OHRS, 05/23/18,

[Please include the biobanking and data collection bullets ONLY if this information is specified in the protocol.]

OHRS, 05/17/18,

[Where appropriate, please briefly state that samples will be coded and destroyed.]

OHRS, 01/09/18,

[social and behavioral activity]

OHRS, 01/09/18,

[social and behavioral activity]

OHRS, 01/09/18,

[Select the appropriate paragraph to include as appropriate for the Phase of the study, or add new language as applicable. This section should also clearly explain what portions of the protocol are investigational / experimental as opposed to procedures that are done as standard of care.]


The specimens [will /will not] be identifiable. The specimens [will /will not] be banked for future use.

Data Collection: Data will be collected and shared with an outside collaborator for analysis. The data [will /will not] be identifiable. The data [will /will not] be banked for future use.

[add additional tests or procedures as appropriate].

If these tests show that you are eligible to participate in the research study, you will be eligible to participate in the research study. If you do not meet the eligibility criteria, you will not be able to participate in this research study.

[Include the following bullets, and add/edit/delete as appropriate]Additional research procedures to be performed at the time of screening, but not required to determine eligibility:

Blood tests to look for a marker for your particular type of cancer. HIV tests. You will have blood samples (about ___ tablespoons) taken to

test for HIV (human immunodeficiency virus). The purpose of this routine laboratory test is to determine whether the virus that is associated with Acquired Immune Deficiency (AIDS) that harms the immune system is present in your blood. The results of these tests will appear in your medical record and will be shared with health care workers involved in your care. The test results will be shared with the study sponsor(s), its subcontractors and/or its agents to perform functions relating to the conduct of this research. All positive results will be shared with a health authority (e.g., the State Department of Health) as required by law.

Biobanking: Biological specimens (such as blood, tissue, or saliva) will be collected and shared with an outside lab or collaborator for analysis. The specimens [will /will not] be identifiable. The specimens [will /will not] be banked for future use.


Optional Studies: You will be asked if you want to participate in any optional research. The optional research is described in Section _____. You do not have to agree to participate in the optional studies to participate in the main study.


After the screening procedures confirm that you are eligible to participate in the research study:

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OHRS, 01/09/18,

[If any optional procedures will be performed during the screening period, please list them here with a brief description of the procedure, explicitly indicate it as optional, and refer participants to the optional section for more information.]

OHRS, 05/23/18,


OHRS, 01/09/18,

[This section typically lists the procedures that must be completed before registration, but are not procedures to determine eligibility]


[Describe in detail the study procedures] Study Visit: [Add here a Visit Description]

This visit will involve the following: Questionnaires or Surveys: Clinical Exams: During this visit you will have a physical exam and you

will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.

Performance status, which evaluates how you are able to carry on with your usual activities.

Biobanking: Biological specimens (such as blood, tissue, or saliva) will be collected and shared with an outside lab or collaborator for analysis. The specimens [will /will not] be identifiable. The specimens [will /will not] be banked for future use.


Optional Studies: You will be asked if you want to participate in any optional research. The optional research is described in Section _____. You do not have to agree to participate in the optional studies to participate in the main study.


After the final intervention: [Explain the follow-up procedures]

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OHRS, 01/09/18,

[For example: We would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year 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 research study.]

OHRS, 01/09/18,

[If any optional procedures will be performed during the screening period, please list them here with a brief description of the procedure, explicitly indicate it as optional, and refer participants to the optional section for more information.]

OHRS, 05/23/18,


OHRS, 01/09/18,

[If appropriate, please describe the study visit here in paragraph form. Where appropriate, please briefly state that samples will be coded and destroyed.]

OHRS, 01/09/18,

[If questionnaires or surveys are involved, state whether the participants can choose to not answer certain questions. Include the amount of time that will be required to complete the questionnaires or survey instruments.]


Example of a simplified chart:

Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Every 4 weeks

Every 8 weeks

Final VisitScreening Day 1 Day 15 Day 29 Day 57

Survey X X X X X X X XBlood Test X X X X X X X XCT Scan X X XTissue Collection XOptional Research X XEtc... X X X X XEtc... X X X X XEtc... X X X X XEtc.. X X X X

C. WHAT ARE THE RISKS OR DISCOMFORTS OF THE RESEARCH STUDY?

There are risks to taking part in any research study.

[Describe all risks in detail.]

During the research study, you will be provided with any new information that may affect your health or willingness to participate. You may be asked to sign a new consent form that shows that you have been informed of new information relating to this research study.

[Include the following part if the research involves biobanking, and edit as needed] Risks of Tissue Collection for Biobanking:Generally, hospitals will keep some of your tissue. There is a small risk that when this tissue is collected and the sample is submitted to the biobank, your tissue could be used up and unavailable for use in the future.

D. WHAT WILL HAPPEN IF I AM REMOVED FROM THE STUDY OR DECIDE TO END MY PARTICIPATION IN THE RESEARCH?

You may be taken off the research study for any reason including: It is considered to be in your best interest The study intervention or procedures are found to be unsafe or ineffective There is any problem with following study intervention and procedures

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OHRS, 01/09/18,

Include any non-physical risks which may include social, psychological, or economic harm; risk of criminal or civil liability; or damage to financial standing, employability or reputation. Include information on the types of assistance that will be made available such as counseling.If psychological distress may result, describe:How this will be identifiedWhat follow-up plan will be in placeWhat additional safeguards will be provided to participants]

OHRS, 01/09/18,

[If appropriate, include a simple table. The schema from the protocol should not be used as it is usually too complex. The main purpose of the table is to tell participants when the procedures described above will be conducted.]


[Include this bullet only if appropriate] You are a female and become pregnant or plan to become pregnant

Your condition worsens A decision is made to end the study Or for other unforeseen reasons that make it necessary to stop your

participation in the research study

You can also choose to stop participating in the research study at any time. Tell the research doctor if you are thinking about stopping or decide to stop. He or she will tell you how to stop. Leaving the research study will not affect your medical care outside of the research study.

[Include the following if the protocol includes provisions for the withdrawal/destruction of identifiable and/or deidentified samples and/or data, and edit as needed. If the protocol does not include provisions for the withdrawal/destruction of identifiable samples, please state so here]

If you agree to allow your ____ to be kept for future research with identifying information that could link your sample to you, you may withdraw your permission at any time. We ask that you contact your study doctor and let them know you are withdrawing your permission for your identifiable ____ to be used for future research.

[Include the following if any samples and/or data will be anonymized/ deidentified, and edit as needed.]If you decide to withdraw from a study that involves [anonymized/ de-identified] [samples and/or data], it will not be possible to remove the [samples and/or data] that have already been submitted to a [database or biobank].

E. WILL I BE PAID TO TAKE PART IN THIS RESEARCH STUDY?

[Please state whether participants will receive payment for participating in this study]-OR-[Include the following paragraph if applicable]You will not be paid for participating in this study.

[Include the following paragraph if applicable]

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OHRS, 01/09/18,

Please do not include details about the reimbursement plan

OHRS, 01/09/18,

[Please do not include details about the reimbursement plan]

OHRS, 01/09/18,

[If they will receive payment, please describe. Please note that this section should not be used to describe compensation for research related injuries. Please include any informational handouts regarding reimbursement for IRB review.]

OHRS, 01/09/18,

[tissue/blood/cells or data]

OHRS, 01/09/18,

[tissue/blood/cells or data]

OHRS, 01/17/18,

[Please ensure that this section describes the process for the withdrawal/ destruction of identifiable samples, and that it is consistent with the information presented in the protocol]


The study sponsor may reimburse you for qualifying study-related travel costs and/or expenses. Study staff will review the reimbursement plan and any requirements for reimbursement with you.

[Include the following paragraph if ClinCard will be used to reimburse participants]This research study will use a service called ClinCard® by the company Greenphire to manage all payments associated with your participation in study visits, your time and travel related to participation in the study. Additional information about the service will be provided to you in a separate document.

[Include the following paragraph if biospecimens are being collected] We may use your samples and information to develop a new product or medical test to be sold. The sponsor and hospital may benefit if this happens. There are no plans to pay you if your samples are used for this purpose.

F. WHAT ARE YOUR COSTS?

Taking part in this research study will / may / will not lead to added costs to you or your insurance company. [Include the following Sentence if applicable and edit as applicable] This may mean that you need to make more visits to the clinic or hospital than if you were getting the usual approach to treat your disease. You may:

Have more travel costs Need to take more time off work Have other additional personal costs

[Include the following Sentence if applicable]You will not be charged for ____. [Include the following Sentence if applicable]It is possible that ____ may not continue to be supplied free for some reason. If this would occur, your research doctor will talk with you about your options.

You or your insurance company will be charged for portions of your care during this research study that are considered standard care, _____. Standard of care is the care that you would receive regardless of whether you were enrolled in the study or not. You may be responsible for co-payments, co-insurance, premiums and deductibles that are typical for your insurance coverage. [Include the following Sentence if applicable and edit as applicable] This includes the cost of tests, procedures, or medicines to manage any side effects, unless you are told that certain tests, done for research only, are supplied at no charge.

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OHRS, 01/09/18,

[if applicable, add “including the following study drugs….”]

OHRS, 01/09/18,

[insert study intervention]

OHRS, 01/09/18,

[insert study intervention]

OHRS, 01/09/18,

[NOTE: Please state whether the cost of the study intervention will be covered. Please do not list who will cover payment for costs for procedures because they might conflict with the billing grids but please make it clear if administration of the intervention will be billed to the participant or their insurance.]

OHRS, 01/09/18,

[Required element of consent: Statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.]


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 institutions] 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 Beth Israel Deaconess Medical Center – Needham (BIDMC-Needham):

(617) 667-5661 Brigham and Women’s Hospital/Faulkner Hospital: (617) 632-3455 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 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 Lowell General Hospital: (978) 937-6600 New Hampshire Oncology-Hematology, P.A.: (603) 622-6484

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

www.cancer.gov or 1-800-4-CANCER (1-800-422-6237)

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http://www.cancer.gov/


G. WHAT HAPPENS IF I AM INJURED OR BECOME SICK BECAUSE I TOOK PART IN THIS RESEARCH STUDY?

[Include this section without any edits if applicable for the study.]

If you think you have been injured as a result of taking part in this research study, tell the person in charge of this research study as soon as possible. The research doctor’s name and phone number are listed in this consent form.

The treating hospital will offer you the care needed to treat injuries directly resulting from taking part in this research. These treatments may be billed to you or your insurance company. You will be responsible for deductibles, co-payments and co-insurance. There are no plans to pay you or give you other compensation for the injury.

You do not give up your legal rights by signing this form.

We will need to collect certain personal information about you for insurance or payment reporting purposes, such as your name, date of birth, gender, social security number or Medicare identification number and information related to this research study. We may be required to report this information to the Centers for Medicare & Medicaid Services. We will not use this information for any other purpose.

If you go to the Emergency Room or to another hospital or doctor it is important that you tell them that you are in this research. If possible, you should give them a copy of this consent form.

[For industry sponsored trials where the sponsor will offer injury coverage, the following statement below may be included after the second paragraph above without revision. If not industry sponsored or if N/A, please delete.]

The study sponsor _____ may pay for the cost of medical treatment. The treating institution and the study sponsor will be responsible for determining what costs may be covered by the study sponsor. You or your insurance company will still be responsible for costs that are not covered by the study sponsor.

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OHRS, 01/09/18,

[Enter Sponsor name.]

OHRS, 01/09/18,

If the sponsor requests changes, note that the IRB will not approve language that:Attempts to define a research-related injury (for example, by specifically excluding pre-existing conditions and underlying disease)Attempts to impose standards of behavior on participants (for example, “Sponsor will pay your costs if you followed the study team directions”)Attempts to limit the amount of coverage that will be provided (for example, “Sponsor will pay your reasonable medical costs only,” or “Sponsor will not pay for lost wages”)Includes legal or not lay-friendly terminology (for example, “Sponsor will not pay if the investigator was negligent or engaged in willful misconduct”)Discusses the Sponsor’s obligations versus the institution’s (for example, “Sponsor will not pay if the study team did not follow the protocol”)Appears contractual or is potentially exculpatory (for example, “You agree that Sponsor is not responsible”)]


H. 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:

[Example:Dana-Farber Cancer Institute

Chris Smith, MD: (617) 632-0000 Pat Black, RN, NP: (617) 632-0000

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 as a research participant, please contact a representative of the Office for Human Research Studies at Dana-Farber Cancer Institute (617) 632-3029. This can include questions about your participation in the study, concerns about the study, a research related injury, or if you feel/felt under pressure to enroll in this research study or to continue to participate in this research study.

I. RETURN OF RESEARCH RESULTS [Please include the language directly below if the results will not be shared. If the results will be shared, please include one of the bottom two options as applicable]

Tests done on samples in this research study are only for research and have no clear meaning for your health care. For this reason, your study doctor will not share the results with you.

OR[If research tests that are done on any sample where the results will be used to make a decision about a participant’s treatment, diagnosis, and/or patient insurance will be billed for the research test, the following language should be included] Tests done on samples in this research study, with your identifiable information, will give results that have meaning for your health care. Your study doctor will

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OHRS, 01/09/18,

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

OHRS, 01/09/18,

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


share the [xxx] clinically relevant research test results with you. If you do not wish to receive the results from these research tests, please notify your study doctor.

OR

[If research results will not be available until a later time after the study completes]

Tests done on samples in this research study, with your identifiable information, will give results that have meaning for your health care. These results, including [xxx] will be available to be shared with you on [insert date]/ OR at the time the study is completed. If you do not wish to receive the results from these research tests, please notify your study doctor.

J. CLINICALTRIALS.GOV (CT.GOV) [Include this section when applicable without any modification to the language]A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This web site will not include information that can identify you. At most, the web site will include a summary of the results. You can search this web site at any time.

K. FUTURE USE OF DATA AND SPECIMENS [Include either the top or bottom part for all studies, and edit as needed. Please ensure this section reflects what is required per protocol, and any optional future research is described in the optional section]Your personal information and/or biospecimens collected during this study may be stored and used for future research. Any personal identifiers [will/will not] be removed, before they are shared, so that the information or samples [can/cannot] be linked back to you. [Include this sentence ONLY if the data/specimens will be anonymized/ de-identified] As a result, we will no longer be able to identify and destroy them.

Investigators, including investigators from collaborating institutions, can request this data and samples for new research. Samples and data may also be shared with outside non-profit academic investigators as well as with for-profit pharmaceutical investigators or commercial entities, with whom we collaborate.

You will not be asked to provide additional informed consent for the use of your [identifiable/de-identified/anonymized] information or samples in future research.

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OHRS, 01/09/18,

[For all Clinical Trials registered on clinicaltrials.gov (DF/HCC SOP REGIST-200) participants must be notified in the informed consent document that clinical trial information has been or will be submitted for inclusion in the clinical trial registry databank.]

http://www.ClinicalTrials.gov/


Future research studies may include genetic research. Your genes are unique to you. At this time, you cannot be identified through this research, if the samples and specimens are [de-identified/anonymized]. There is a risk that you might be reidentified in the future as genetic research progresses

-OR-

Your personal information and/or biospecimens collected during this study will not be used or distributed for future research studies even if the information is [anonymized/de-identified] and cannot be linked back to you.

-AND/OR-

[Please ONLY include the following for industry-sponsored research where it is applicable]This protocol also involves optional research regarding the future use of specimens and/or data. Please refer to [section X of this consent form/the separate optional consent form] for more information regarding this optional research, and to indicate whether or not you’d like to participate.

L. CONFIDENTIALITY

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

[Include the following paragraph if medical information will become part of the hospital medical record] Medical information created by this research study may become part of your hospital medical record and may be forwarded to your primary doctor. Information that does not become part of your medical record will be stored in your study file. It may also become part of a research database.

[Include the following paragraph if the protocol involves the collection of tissue.]Participation in this study involves providing a specimen of your tissue; please know that if the research doctor leaves the institution, the research and the tissue might remain at the research doctor’s current institute or might be transferred to another institution.

The study team plans to publish the results of this research study and when we do, we may be asked to make the data we collect available to other researchers.

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We will not include information that identifies you in any publications or to the researchers who request the data to do additional research.

[Include the following ONLY if Section M includes the provision for the future use of data and specimens]Your [anonymized/ de-identified] specimens or genetic data may also be placed into one or more publicly-accessible scientific databases. Through such databases, researchers from around the world will have access to [anonymized/de-identified] samples or data for future research.

There is a risk that deidentified research data that is shared with outside collaborators may be reidentified. When deidentified data and specimens are shared with outside collaborators agreements limit what the outside collaborators can do with the information to help prevent reidentification.

M. FINANCIAL DISCLOSURES [Include the following language below. Please note that if separate faculty conflict of interest management plan is developed and required by the Office for Research Integrity and the DFCI IRB, this language should be replaced with the disclosure language provided and approved by the IRB]

It is possible that certain researchers on this study may have earned money from, or own some publicly-traded stock in, the company that makes or is developing the study [drug/device/intervention/other: please specify]. The amount of money that a researcher may earn and still take part in research is limited by the Harvard Medical School Faculty of Medicine Policy on Conflicts of Interest and Commitment. If you have further questions, please speak with a member of the study team or contact the Dana-Farber Cancer Institute Office of Research Integrity at 617-432-4557 or [email protected].

[If an institutional conflict of interest or study team member conflict of interest has been identified by the Dana-Farber Cancer Institute Office of Research Integrity and is subject to a management plan, please insert the appropriate consent disclosure language here (as required under the terms of the management plan). Otherwise, please delete]

N. CERTIFICATE OF CONFIDENTIALITY (COC)

[If this study is NIH funded and the research commenced (or is ongoing) on or after December 13, 2016 it has been issued a Certificate of Confidentiality. The following language is required in the consent form.]

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mailto:[email protected]


To help protect your privacy, we have been issued a Confidentiality Certificate from the National Institutes of Health (NIH). With this Certificate, the researchers on this study cannot be forced (for example, by court subpoena) to disclose information that may identify you in federal, state, or local civil, criminal, administrative, legislative or other proceedings.

Disclosure will be necessary upon request of a United States federal or state government agency sponsoring the project that will be used for audit or program evaluation purposes or to meet the requirements of the federal Food and Drug Administration (FDA).

You should understand that a Certificate of Confidentiality does not prevent you or a member of your family or even the research doctor from voluntarily releasing information about yourself or your involvement in this research. If an insurer, medical care provider, or employer learns about your participation, and obtains your consent to receive research information, then we cannot use the Certificate of Confidentiality to withhold this information. This means that you and your family must actively protect your own privacy.

The Certificate of Confidentiality cannot be used to prevent disclosure to state or local authorities when there is a duty to report concerns of abuse, neglect, self-harm or a danger to others.

[If your study is not NIH funded, but a Certificate of Confidentiality (CoC) has been obtained please include this section. If you choose to include sponsor language, please remove duplicative information.]

To help protect your privacy, ____ has obtained a Confidentiality Certificate from the Department of Health and Human Services (DHHS). With this Certificate, ____ cannot be forced (for example, by court subpoena) to disclose information that may identify you in federal, state, or local civil, criminal, administrative, legislative or other proceedings.

Disclosure will be necessary upon request of a United States federal or state government agency sponsoring the project that will be used for audit or program evaluation purposes or to meet the requirements of the federal Food and Drug Administration (FDA).

You should understand that a Certificate of Confidentiality does not prevent you or a member of your family or even the research doctor from voluntarily releasing

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OHRS, 01/10/18,

[add name of organization obtaining the certificate]

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information about yourself or your involvement in this research. If an insurer, medical care provider, or employer learns about your participation, and obtains your consent to receive research information, then ____ cannot use the Certificate of Confidentiality to withhold this information. This means that you and your family must actively protect your own privacy.

The Certificate of Confidentiality cannot be used to prevent disclosure to state or local authorities when there is a duty to report concerns of abuse, neglect, self-harm or a danger to others.

O. GENETIC RESEARCH [Include this section ONLY if the protocol involves the use of retrospective or prospective samples. Otherwise, please delete this section]

[Include the following if the research on the samples will not involve genomic testing and/or germline testing] This research will not involve genomic or germline testing.

[OR]

[Include the following if the research on the samples will involve genomic testing and/or germline testing] This research will involve genomic [and/or] germline testing.

[Include this section if the research involves genomic testing and/or germline testing] The Genetic Information Nondiscrimination Act of 2008 (GINA) is a federal law that protects Americans from being treated unfairly because of differences in their DNA that may affect their health, and may prevent discrimination by health insurers and employers based on genetic information. GINA is intended to ease concerns about discrimination that might keep some people from getting genetic tests that could benefit their health, and enable people to take part in research studies such as this without fear that their DNA information might be used against them by health insurers or their workplace. This protection does not extend to disability or life insurance. Additional information can be found athttp://www.genome.gov/10002328.

[Remove this paragraph if the study will not share data/specimens with dbGaP]As part of this study, your [anonymized/de-identified] specimens or genetic data may be placed into one or more publicly-accessible scientific databases, such as

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OHRS, 01/10/18,


http://www.genome.gov/10002328


the National Institutes of Health's Database for Genotypes and Phenotypes (dbGaP). Through such databases, researchers from around the world will have access to [anonymized/ de-identified] samples or data for future research.

P. PRIVACY OF PROTECTED HEALTH INFORMATION (HIPAA AUTHORIZATION) [This section can ONLY be edited as indicated in the template below]

The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that requires Dana-Farber/Harvard Cancer Center (DF/HCC) and its affiliated research doctors, health care providers, and physician network to protect the privacy of information that identifies you and relates to your past, present, and future physical and mental health conditions (“protected health information”). If you enroll in this research study, your “protected health information” will be used and shared with others as explained below.

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

Existing medical records, including mental health records. New health information created from study-related tests, procedures,

visits, and/or questionnaires

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

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

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

or situations where you or others may be at risk of harm); and To provide the study sponsor with information arising from an adverse

event or other event that relates to the safety or toxicity of the drug(s) used in the study and for the purpose of this or other research relating the study drug(s) and their use in cancer;

To better understand the diseases being studied and to improve the design of future studies; and,

Other reasons may include for treatment, payment, or health care operations. For example, some medical information produced by this research study may become part of your hospital medical record because

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the information may be necessary for your medical care. (You will also be given a notice for use and sharing of protected health information.)

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

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

4. With whom outside of DF/HCC may my protected health information be shared?

While all reasonable efforts will be made to protect the confidentiality of your protected health information, it may also be shared with the following entities:

Outside individuals or entities that have a need to access this information to perform functions relating to the conduct of this research such as analysis by outside laboratories on behalf of DF/HCC and its affiliates (for example, data storage companies, insurers, or legal advisors).

The sponsor(s) of the study, its subcontractors, representatives, business partners, and its agent(s): ____

Other research doctors and medical centers participating in this research, if applicable

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

Hospital accrediting agencies A data safety monitoring board organized to oversee this research, if

applicable Other, ____

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.

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[please specify]

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[Enter the names of all sponsors. If applicable, include the following: The sponsor may send study data outside of the U.S.]


5. For how long will protected health information about me be used or shared with others?

There is no scheduled date at which your protected health information that is being used or shared for this research will be destroyed, because research is an ongoing process.

6. Statement of privacy rights:

You have the right to withdraw your permission for the research doctors and participating DF/HCC entities to use or share your protected health information. We will not be able to withdraw all the information that already has been used or shared with others to carry out related activities such as oversight, or that is needed to ensure quality of the study. To withdraw your permission, you must do so in writing by contacting the researcher listed above in the section: “Whom do I contact if I have questions about the research study?”

You have the right to request access to your protected health information that is used or shared during this research and that is related to your treatment or payment for your treatment, but you may access this information only after the study is completed. To request this information, please contact the researcher listed above in the section: “Whom do I contact if I have questions about the research study?”

Q. CONSENT TO OPTIONAL RESEARCH STUDIES:

[Include this section if there are optional research studies or procedures, and edit/add/delete language to fit the specifics of the study.]

You are being asked to participate in some optional studies. If you decide not to participate in any of the optional studies, you can still participate in the main research study. Please take your time to make your decision and discuss it with others and your primary care physician.

Your participation in these optional research studies is voluntary, and you will not be penalized or lose any benefits if you refuse to participate or decide to stop.

Optional Study #1:

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[If there are optional research studies or procedures, please briefly describe them where indicated and for each optional study please include the template lines for participants to indicate their choice. Please add as many template Optional Study sections as needed including a sequential identification number for each added Optional Study. Any optional studies described in this consent form must also be described in the protocol.]


[Please describe the first Optional Study here. Please include a brief description of the procedure/assessment, purpose, risks and what will be done with the results]

Please indicate whether or not you want to take part in this optional research study.

Not applicable

Yes Initials Date

No Initials Date

Optional Study #2:


Not applicable

Yes Initials Date

No Initials Date

Optional Study #3:


Not applicable

Yes Initials Date

No Initials Date

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R. DOCUMENTATION OF ASSENT

[Include this section if the study involves children AND if you expect assent will 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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S. 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 remainder of this section (i.e., second signature line) 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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To be completed by person obtaining consent:

Adult Participant

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

Signature of Interpreter/Witness:

Printed Name of Interpreter/Witness:

Date:

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

The participant is illiterate.

The participant has a physical disability.

Other (please describe): _________________________________________

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

Signature of Witness:

Printed Name of Witness:

Date:

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2) The participant is an adult who lacks capacity to provide consent and his/her legally authorized representative:

2a) gave permission for the adult participant to participate

2b) did not give permission for the adult participant to participate

To be completed by person obtaining consent:

Minor Participant

The consent discussion was initiated on (date).

Signature of individual obtaining consent:


Date:

A copy of this signed consent form will be given to the participant or legally authorized representative, or, where the participant is a minor, the participant’s parent or legal guardian.

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

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

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

Signature of Interpreter/Witness:

Printed name of Interpreter/Witness:

Date:

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

The participant is illiterate.

The participant has a physical disability.

Other (please describe): _________________________________________

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The consent form was presented to the parent or legally authorized representativewho was given the opportunity to ask questions and who communicated agreement for

the minor to participate in the research.

Signature of Witness:

Printed Name of Witness:

Date:

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

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