PROTOCOL TITLE: Type over this box - Home - DF/HCC



Protocol Title: Sponsor Protocol Number: DF/HCC Principal Investigator(s) / Institution(s): Addendum Title: [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 continue to participate. IntroductionThis consent addendum gives new information about the research study in which you agreed to participate. Your research doctor or a designated member of the research team will discuss this new information with you. The [risks and/or new procedures, etc.] noted below are in addition to those which you were informed about in the previous consent form. The decision to continue to participate is yours. If you decide to continue to participate, please sign and date at the end of this form. We will give you a copy so that you can refer to it while you are involved in this research study. If you choose not to continue to participate in this research study, the research doctors will discuss other treatment options with you and/or refer you back to your primary doctor. 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 now and at any time in the future.Brief description of the project What are the new risks, additional information?What are the new procedures?If you agree to continue your participation in this study, you will be asked to _____.[Include if the new procedure is optional:]Please indicate whether or not you want to take part in this optional research procedure. Not applicable Yes Initials Date No Initials DateWho do I contact if I have questions or a research-related problem?If you have further questions about the study or if you have a research-related problem, please contact the research doctor or staff 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.Documentation of Assent[Delete this Assent Section if the research DOES NOT involve children or if you expect Assent will not be required by the IRB.]Signature of participant between age of 10 and 18: The person doing this research study has explained the information to me. My signature below means that I want to continue to be in this research study. I can decide not to continue 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 continue to participate. ______________________________________________________Signature of ParticipantDateTo 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 continue to take part in the study FORMCHECKBOX Did not agree to continue to take part in the study FORMCHECKBOX An assent discussion was not initiated with the minor for the following reason(s): FORMCHECKBOX Minor is incapacitated FORMCHECKBOX Minor is under 10 years of age FORMCHECKBOX OtherSignature of Individual obtaining assent: Printed name of above: Date: Documentation of ConsentMy signature below indicates:I have had enough time to read the consent addendum and think about continuing to participate in this study;I have had all of my questions answered to my satisfaction;I am willing to continue to participate in this study;I have been told that my continued participation is voluntary and I can withdraw at any timeSignature of ParticipantDateor Legally Authorized Representative Relationship of Legally Authorized Representative to Participant [Please include the second signature line below ONLY if the IRB has determined that a second signature is required.]My signature below indicates:I have had enough time to read the consent addendum and think about continuing to participate in this study;I have had all of my questions answered to my satisfaction;I am willing to continue to participate in this study;I have been told that my continued participation is voluntary and I can withdraw at any timeSecond Signature of Legally Authorized RepresentativeDateRelationship 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 addendum will be given to the participant or legally authorized representative. FORMCHECKBOX 1) The participant is an adult and provided consent to continue to participate. FORMCHECKBOX 1a) Participant (or legally authorized representative) is a non-English speaker andsigned the translated Short Form in lieu of English consent document:As someone who understands both English and the language spoken by the participant, I interpreted and/or witnessed, in the participant’s language, the researcher’s presentation of the English consent form. The participant was given the opportunity to ask questions. Signature of Interpreter/Witness: Printed Name of Interpreter/Witness: Date: FORMCHECKBOX 1b) Participant is physically unable to sign the consent form addendum because: FORMCHECKBOX The participant is illiterate. FORMCHECKBOX The participant has a physical disability. FORMCHECKBOX Other (please describe): _________________________________________ The consent form addendum 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: 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 continue to participate FORMCHECKBOX 2b) did not give permission for the adult participant to continue to participate To be completed by person obtaining consent:Minor 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 addendum 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 continue to participate. FORMCHECKBOX 1a) Parent or legally authorized representative is a non-English speaker and signedthe translated Short Form in lieu of English consent documentAs 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: FORMCHECKBOX 1b) Parent or legally authorized representative is physically unable to sign the consent form addendum because: FORMCHECKBOX The participant is illiterate. FORMCHECKBOX The participant has a physical disability. FORMCHECKBOX Other (please describe): _________________________________________The consent form addendum was presented to the parent or legally authorized representative who was given the opportunity to ask questions and who communicated agreement for the minor to continue to participate in the research. Signature of Witness: Printed Name of Witness: Date: FORMCHECKBOX 1c) The parent or legally authorized representative did not give permission for the minor to continue to participate ................
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