PROTOCOL TITLE: Type over this box



4871333-1087589Protocol Title: Sponsor Protocol Number: DF/HCC Principal Investigator(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” as used throughout this document refers to your child. The parent or guardian is asked to read and sign this document and to give permission for their 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]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.” 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 this research study because you have ____.Why is this research being done? [Tell the subject the purpose/ objective of the research in a brief statement].Who is supporting this research? _____ is funding this research study by providing ____. 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:QuestionnairesData CollectionSample CollectionThe 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_______ and will be followed for ______.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 common risks right now. More information about [these risks and additional risks/other additional risks] are provided in “Section C. What are the risks or discomforts of the research study?”.Major known risks to participating in this research study include: [e.g.Disclosure of sensitive personal information may result is a loss of privacyPossible emotional distress due to personal questionsSignificant amount of time required to complete questionnaires (online and/or in person)Significant amount of time required to attend study visits]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. 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 studyParticipate in another research study.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.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.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.It is expected that about ____ people will take part in this research study. 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. For details regarding future use and confidentiality please see the “Future Use of Data and Specimens” and “Confidentiality” sections below. Data Collection: Data will be collected and shared with an outside collaborator for analysis. The data [will /will not] be identifiable. For details regarding future use and confidentiality please see the “Future Use of Data and Specimens” and “Confidentiality” sections below. [Remove reference to Future Use if there is no Future Use for data collection] 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 as appropriate, and add/edit/delete as applicable]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. For details regarding future use and confidentiality please see the “Future Use of Data and Specimens” and “Confidentiality” sections below.Data Collection: Data will be collected and shared with an outside collaborator for analysis. The data [will /will not] be identifiable. For details regarding future use and confidentiality please see the “Future Use of Data and Specimens” and “Confidentiality” sections below. [Remove reference to Future Use if there is no Future Use for data collection]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. [add additional tests or procedures as appropriate].After the screening procedures confirm that you are eligible to participate in the research study: [Describe in detail the study procedures] Study Visit: [Add here a Visit Description[If appropriate, please describe the study visit here in paragraph or bullet form.]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. For details regarding future use and confidentiality please see the “Future Use of Data and Specimens” and “Confidentiality” sections below. Data Collection: Data will be collected and shared with an outside collaborator for analysis. The data [will /will not] be identifiable. For details regarding future use and confidentiality please see the “Future Use of Data and Specimens” and “Confidentiality” sections below. [Remove reference to Future Use if there is no Future Use for data collection]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. [add additional tests or procedures as appropriate].After the final intervention: [Explain the follow-up procedures]Example of a simplified chart:Visit 1Visit 2Visit 3Visit 4Visit 5Every 4 weeksEvery 8 weeksFinal VisitScreeningDay 1Day 15Day 29Day 57SurveyXXXXXXXXBlood TestXXXXXXXXCT ScanXXXTissue CollectionXOptional ResearchXXEtc...XXXXXEtc...XXXXXEtc...XXXXXEtc..XXXXWhat are the risks or discomforts of the research study?There are risks to taking part in any research study, including the possibility of a breach of confidentiality. However, we will take steps to minimize the risk[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. 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.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 interestThe study intervention or procedures are found to be unsafe or ineffectiveThere is any problem with following study intervention and procedures[Include this bullet only if appropriate] You become pregnant or plan to become pregnantYour condition worsensA decision is made to end the studyOr for other unforeseen reasons that make it necessary to stop your participation in the research studyYou 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. They 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]What are the benefits of this research study?Taking part in this research study may or may not benefit you. We hope the information learned from this research study will provide more information about_______. [This section of the consent document should identify one or more likely benefits resulting from participation in the study. First, describe any direct benefits, then any benefits to others. If there are no benefits, please state this.]Will I be paid to take part in this research study?[Please state whether participants will receive direct payment for their participation in this study]-OR-[Include the following if participants are not receiving direct payment for their participation]You will not be paid for participating in this study. [In addition to the above, include any of the following if applicable:][Include the following paragraph if applicable]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 pay or reimburse participants at DFCI]For participants who enroll at the Dana-Farber Cancer Institute, 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. [For studies that involve compensation] The specific details of the payment plan will be given to you by the study team in a separate document. [For all studies utilizing a ClinCard] Additional information about the service is available separate documents at the following website: . You can also request these documents from the study team if you would like them in paper form. [For studies that involve reimbursement]Please note that it is very important that to save any receipts for items you would like reimbursed other than for mileage. You will need to give these receipts to the study team to receive reimbursement.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 costsNeed to take more time off workHave 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 routine costs. Routine costs may include services to determine your eligibility, services to prevent (monitor) and diagnose disease, and services to treat side effects. Examples of research study routine costs may include the infusion of the study medicines, office visits, lab tests, procedures, and imaging.You may be billed for co-payments, co-insurance, premiums and deductibles that are typical for your insurance coverage. Participation may result in additional routine costs because of more frequent research visits. 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) 667-5661Boston Children’s Hospital: (617) 355-7188Brigham and Women’s Hospital: (617) 732-5524 or (617) 732-7485Dana-Farber Cancer Institute: (617) 632-3455Massachusetts General Hospital: (617) 726-2191Beth Israel Deaconess Medical Center – Needham (BIDMC-Needham): (617) 667-5661Brigham and Women’s Hospital/Faulkner Hospital: (617) 632-3455Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in clinical affiliation with South Shore Hospital: (781) 624-4329Dana-Farber/New Hampshire Oncology-Hematology: (603) 552-9106Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) at Milford Regional Medical Center: (508) 422-2970Dana-Farber Cancer Institute at Steward St. Elizabeth’s Medical Center: (800) 664-3884Massachusetts General Hospital/North Shore Cancer Center: (617) 726-2191Massachusetts General Hospital at Emerson Hospital - Bethke: (978) 287-3043 or (978) 287-3064Massachusetts General Hospital at Newton Wellesley Hospital: 617-726-3884The Lawrence. & Memorial Cancer Center in affiliation with Dana-Farber Community Cancer Care: (860) 442-0711 ext. 4702Cape Cod Healthcare: (508) 862-7575Lowell General Hospital: (978) 937-6600New Hampshire Oncology-Hematology, P.A.: (603) 622-6484The 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: or 1-800-4-CANCER (1-800-422-6237)What happens if I am injured because I took part in this research study?[Do not include this section for studies that are not considered greater than minimal risk. Please include sponsor language if injuries are being covered by the sponsor, excluding exculpatory language. The IRB will review as appropriate]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.?[For industry sponsored trials where the sponsor will offer injury coverage, include the following statement below without revision.]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.[If the industry sponsor does not offer injury coverage, do not include the language in the paragraph above and instead refer to the paragraph below.]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. However, you do not give up any of 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 and sex assigned at birth, 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.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 InstituteChris Smith, MD: (617) 632-0000Pat Black, RN, NP: (617) 632-0000Example: 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. Return of Research ResultsReturn of Individual Research Results[Include the following text for studies where individual research results will be shared with the participant and/or included in their medical record]For tests done on samples in this research study, any clinically meaningful research results will be shared with you and may be placed in your medical record. If you do not wish to receive the results from these tests, please notify your study doctor.AND/OR[Please include the language directly below if all or some of the individual research results will not be shared]Some tests done on samples in this research study are for research purposes and may have no clear meaning for your health care. For this reason, your study doctor is not intending to share the results with you.OR[If individual research results will not be available until a later time after the study completes]Tests done on samples in this research study are investigational and may or may not have known clinical significance for your health care. These individual results may be available to be shared with you at some point in the future 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. Return of Aggregate ResultsIf aggregate results will be available to share after the study is completed, please note here that a link to a lay summary of the results will be provided in the future. You may also offer an opt out for receiving this information, and that the participant may be asked to provide an email contact if they would like to receive a lay summary of the study results. This language may be altered to fit the method of sharing aggregate results].You may be contacted after the study is completed to ask if you would like to receive a summary of the study results. You will also be given a chance to opt out of this. You may also be asked to share an email address to receive indication that study results are ready to be shared. [Include this section when applicable without any modification to the language]A description of this clinical trial will be available on , 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.Future use of data and Specimens[Include the following if the protocol does NOT involve the future use of data and/or specimens. It is an option only available for non-NIH funded studies or when the data are excluded from the NIH data sharing policy. (requires justification).]Your personal information and/or biospecimens collected during this study will not be used for any future research after this study is complete.[Include the following if the research on the samples may involve somatic genetic tests or whole genomic sequencing] This research may involve somatic genetic tests or whole genomic sequencing including all or part of your DNA. Sequencing allows researchers to identify your genetic code.[Include the following language if the protocol DOES involve the future use of data and/or specimens, and select option #1 if coded or option #2 if de-identified or option #3 if anonymous]This study is collecting data and biospecimens from you. We would like to make your data and biospecimens available for other research studies that may be done in the future. The research may be about similar diseases or conditions to this study. However, research could also be about unrelated diseases, conditions, or other types of research. These studies may be done by researchers at this institution or other institutions, including for-profit entities, such as pharmaceutical companies and other biotechnology companies. Our goal is to make more research gains possible from your contribution. Your [(Select any that apply) anonymized/deidentified/coded] specimens or genetic data may also be placed into one or more scientific databases, some of which are publicly accessible. Through such databases, researchers from around the world will have access to [(Select any that apply) anonymized/deidentified/coded] samples or data for future research. [Option #1: If the data and biospecimens are coded and can be linked back to the identity of the participant]Coded refers to data that no one outside a study team can link to a subject’s identity. We will protect the confidentiality of your information to the extent possible. Your data and biospecimens will be coded to protect your identity before they are shared with other researchers. [indicate which entity has the code key] will have a code key that can be used to link to your identifying information. The code key will be securely stored. If you agree to allow your [samples and/or data] to be kept for future research with identifying information that could link your sample to you, you may withdraw your permission at any time. From the date of your withdrawal, we can remove it from a data repository and prevent further future use. We ask that you contact your study doctor and let them know you are withdrawing your permission for your identifiable [samples and/or data] to be used for future research.[Option #2: If the data and biospecimens are de-identified and cannot be readily linked back to the identity of the participant]De-identified refers to data that used to be fully identifiable or coded, until the researcher destroyed or no longer has access to all of the identifiers linking the data to study subjects. Your name and identifying information will be removed from any data and biospecimens you provide before they are shared with other researchers. Researchers cannot easily link your identifying information to the data and biospecimens. The researchers must agree not to try to identify you.[Option #3: If the data and biospecimens are anonymous]Anonymous refers to data that no one, including members of a study team, can at any point link to a subject’s identity.[Include the following language/paragraph, regardless of whether option #, option #2, or option #3 was selected] We plan to keep your data and biospecimens [indefinitely OR Insert time frame as indicated in the protocol]. Your data and biospecimens may be shared with researchers around the world. However, the decision to share your data and biospecimens is controlled by [indicate which entity has control]. To get your data and biospecimens, future researchers must seek approval from [indicate which entity has control]. 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]. [Include the following language/paragraph, regardless of whether option #, option #2, or option #3 was selected] We may use your samples and information to develop a new product or medical test that has commercial value. The sponsor and/or hospital may benefit if this happens. There are no plans to pay you if your samples are used for this purpose. We will do our best to protect your data and biospecimens during storage and when they are shared. However, there remains a possibility that someone could identify you. There is also the possibility that unauthorized people might access your data and biospecimens. In either case, we cannot reduce the risk to zero. 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 [anonymized/de-identified]. There is a risk that you might be reidentified in the future as genetic research progresses.You will not receive any direct benefit from sharing your data and biospecimens. However, sharing your data and biospecimens may contribute to research that could help others in the future.You will not be asked to provide additional informed consent for the use of your information or samples in future research.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 [anonymized/de-identified]. There is a risk that you might be reidentified in the future as genetic research progresses.[The following statement may be used if the future use of data/specimens is optional. It is an option only available for non-NIH funded studies or when the data are excluded from the NIH data sharing policy. (requires justification)].This protocol also involves optional research regarding the future use of specimens and/or data. Please refer to [section _____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.ConfidentialityWe 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. The study team may 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. We will not include information that identifies you in any rmation 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. 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 researchintegrity@dfci.harvard.edu.[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] 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.]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 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. Genetic Research[Include this section if the protocol involves the collection and use of biological samples for genetic research, or if future use involves the use of biological samples for genetic research.][Include the following if the genetic research on the samples will not involve germline or whole genome sequencing] This research may involve somatic genetic testing but will not involve germline testing. Somatic testing involves testing or sequencing of your tumor and looks for acquired mutations that may have developed due to your cancer. The results are used to plan treatment, including the use of targeted therapy and immunotherapy. [If the study includes whole genome or whole exome sequencing, include the following language.]This research will involve germline testing or genomic sequencing of all or part of your DNA. Sequencing allows researchers to identify your genetic code.Two methods of genetic analysis,?whole exome sequencing and whole genome sequencing, are increasingly used in healthcare and research to identify genetic variations; both methods rely on new technologies that allow rapid sequencing of large amounts of DNA. These approaches are known as next-generation sequencing (or next-gen sequencing).[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 at. [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 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.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.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 questionnairesWhy 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); andTo 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 the information may be necessary for your medical care. (You will also be given a notice for use and sharing of protected health information.)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.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 applicableFederal 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 agenciesA data safety monitoring board organized to oversee this research, if applicableOther, ____ 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. 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. 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?”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:[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. Include one of the data/specimens use options from Section L. to describe the data/specimens set.]Please indicate whether or not you want to take part in this optional research study. Not applicable Yes Initials Date No Initials DateOptional Study #2: Please indicate whether or not you want to take part in this optional research study. Not applicable Yes Initials Date No Initials DateOptional Study #3: Please indicate whether or not you want to take part in this optional research study. Not applicable Yes Initials Date No Initials Date[Include the following paragraph if biospecimens are being collected for any of these optional studies. This paragraph does not need to be included if this paragraph was already included in the Future Use of Data and Specimens section above] We may use your samples and information to develop a new product or medical test that has commercial value. The sponsor and/or hospital may benefit if this happens. There are no plans to pay you if your samples are used for this purpose. DOCUMENTATION OF CONSENTMy 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 timeSignature of ParticipantDate[Please use this section when it is anticipated that a Legally Authorized Representative will be signing on behalf of a participant, and it is noted in the protocol.]Please sign here when a Legally Authorized Representative will sign on behalf of the Participant:Signature of Legally AuthorizedDateRepresentative Relationship of Legally Authorized Representative to Participant To be completed by person obtaining consent:Adult ParticipantThe consent discussion was initiated on (date).Signature of individual obtaining consent: Printed name of above: Date: FORMCHECKBOX A copy of this signed consent form will be given to the participant or legally authorized representative. FORMCHECKBOX 1) The participant is an adult and provided consent to participate. FORMCHECKBOX 1a) Participant or legally authorized representative is a non-English speaker who received and signed the translated Short Form in lieu of English consent document, and was provided a copy FORMCHECKBOX 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: __________________________________________________Signature of Witness: Interpreter may also serve as Witness if presentPrinted Name of Interpreter: Printed Name of Witness: Date: FORMCHECKBOX 1b) Participant or legally authorized representative is a non-English speaker who received and signed a translated consent form in the language they understand, and was provided a copy FORMCHECKBOX 1c) Participant is unable to sign the consent form because: FORMCHECKBOX The participant is unable to read and write. FORMCHECKBOX The participant has a physical disability. FORMCHECKBOX 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 Interpreter: __________________________________________________Signature of Witness: Interpreter may also serve as Witness if presentPrinted Name of Interpreter: Printed Name of Witness: Date: FORMCHECKBOX 2) The participant is an adult who lacks capacity to provide consent and his/her legally authorized representative: FORMCHECKBOX 2a) gave permission for the adult participant to participate FORMCHECKBOX 2b) did not give permission for the adult participant to participate DOCUMENTATION OF AND PARENTAL PERMISSION AND ASSENT OF THE CHILD [Include this section if the study involves children] [Include the following if you expect assent will be required by the IRB]Signature of participant between age of 10 and 17: 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 also tell the research team if I do not want to take part in this research study and nothing will bad will happen to me.______________________________________________________Signature of Minor ParticipantDatePermission of Parent/Guardian:My signature below indicates:I have had enough time to read the consent and think about my child’s participation in this study;I have had all of my questions answered to my satisfaction;I am willing to have my child participate in this study;I have been told that my child’s participation is voluntary and I can withdraw at any timeSignature of Parent/Legal GuardianDateRelationship of Parent/Legal Guardian to Participant Signature of Parent/Legal GuardianDateRelationship of Parent/Legal Guardian to Participant If signature of second parent was required by the IRB and not obtained, indicate why: (select one)Only one parent has legal responsibility for the care and custody of the childSecond parent is deceasedSecond parent is unknown Second parent is incompetentSecond parent is not reasonably availableTo be completed by person obtaining assent:The assent discussion was initiated on (date). FORMCHECKBOX The information was presented in age-appropriate terms. The minor: FORMCHECKBOX Agreed to take part in the study FORMCHECKBOX Did not agree to take part in the study FORMCHECKBOX An assent discussion was not initiated with the minor for the following reason(s): FORMCHECKBOX Minor is not able to understand or has a condition that prevents assent discussion FORMCHECKBOX Minor is under 10 years of age FORMCHECKBOX OtherSignature of Person Obtaining Assent: Printed name of above: Date: To be completed by person obtaining permission from the parent:The permission from parent discussion was initiated on (date).Signature of individual obtaining permission from parent: Printed name of above: Date: FORMCHECKBOX 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. FORMCHECKBOX 1) The parent or legally authorized representative gave permission for the minor to participate. FORMCHECKBOX 1a) Parent or legally authorized representative is a non-English speaker who received and signed the translated Short Form in lieu of English consent document, and was provided a copy FORMCHECKBOX 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: __________________________________________________Signature of Witness: Interpreter may also serve as Witness if presentPrinted Name of Interpreter: Printed Name of Witness: Date: FORMCHECKBOX 1b) Parent or legally authorized representative is a non-English speaker who received and signed a translated consent form in the language they understand, and was provided a copy FORMCHECKBOX 1c) Parent or legally authorized representative is physically unable to sign the consent form because: FORMCHECKBOX The participant is unable to read and write. FORMCHECKBOX The participant has a physical disability. FORMCHECKBOX Other (please describe): _________________________________________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 Interpreter: __________________________________________________Signature of Witness: Interpreter may also serve as Witness if presentPrinted Name of Interpreter: Printed Name of Witness: Date: FORMCHECKBOX 1c) The parent or legally authorized representative did not give permission for the minor to participate ................
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