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Modelo de consentimiento informado

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Modelo de Consentimiento Informado (Español a Inglés) - Todos los Derechos Reservados por Tradunova Perú

Modelo de Consentimiento Informado (Español a Inglés) - Todos los Derechos Reservados por Tradunova Perú

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Modelo de consentimiento informado Modelo de consentimiento informado Document Transcript

  • Protocol BO25126 CRTN 232448José Zorrilla Silvera, M.D.Centro de Investigación Clínica Trujillo EIRL – Clínica Peruano AmericanaINFORMED CONSENT FORM FOR THE OPTIONAL DONATION OF FROZEN TUMOR TISSUEProtocol Number: BIG 4-11/BO25126/TOC4939G A randomized multicenter, double-blind, placebo- controlled comparison of chemotherapy plus trastuzumab plus placebo versus chemotherapy plusTitle trastuzumab plus pertuzumab as adjuvant therapy in patients with operable HER2-positive primary breast cancerSponsor: PRODUCTOS ROCHE Q.F.S.A José Zorrilla Silvera, M.D.Principal Investigator Centro de Investigación Clínica Trujillo EIRL –Name of the Institution Clínica Peruano AmericanaAddress: Av. Mansiche 810.–Trujillo – PerúPhone number: (044) - 291520Patient Identification NumberPatient InitialsInvitation to participate in the optional donation of frozen tumor tissue:As a part of your treatment you recently had to undergo a surgery to remove yourHER2-positive breast cancer. You have given your consent to participate in theAPHINITY study, sponsored by F. Hoffmann-La Roche Ltd. represented in Peruby Productos Roche Q.F.S.A., hereinafter referred as Roche, and conducted withthe collaboration of the Breast International Group (BIG, located in Belgium,website: www.breastinternationalgroup.org), a non profit international academicorganization. For this reason, we provide you with this informed consent form.Besides the consent you gave to participate in the APHINITY study, BIG andROCHE wish to request your consent to donate a tumor sample, which has beenremoved by surgery and to allow it to be frozen for research purposes.We invite you to donate this tissue so that it may be used in future scientificresearches. The tumor samples will be moved and stored in the Study SampleRepository (i.e., biological materials bank) in Brussels, Belgium, which will beunder custody of BIG and directed by the directive committee of the APHINITYstudy.Version 1.0 in Spanish dated November 10, 2011, adapted from version 1 in English dated September 20,2011 (Agencia Médica/HS) 1
  • Protocol BO25126 CRTN 232448José Zorrilla Silvera, M.D.Centro de Investigación Clínica Trujillo EIRL – Clínica Peruano AmericanaBefore accepting or rejecting the request for the donation of a tumor sample, youshould understand the reasons for this optional donation and the steps to befollowed. Please, for more information about the terminology or technicalexpressions or any other question or concern about the content of this document,ask your study doctor or staff. Do not sign this form until you are satisfied with theanswers given to your questions and you are decided to give this donationvoluntarily.This is an optional donation: your participation in APHINITY does notoblige to donate a frozen sample of your tumor.What will happen to my frozen tumor sample if I accept to move it to BIG?These samples will be used in future researches and will be subject toevaluations to detect markers that may help to researches related to severalissues such as pertuzumab and trastuzumab treatments, side effects, breastcancer, related diseases and their diagnosis. For this purpose, severaltechniques will be used.This research may include protein analysis, ARN and non hereditary factors(which are not genetically transmitted from a generation to the other) by using thetumor’s ADN.Future scientific researches on the frozen tumor sample may require the analysisof your medical information that has been obtained as a part of the APHINITYstudy. For more information, refer to the specific section on ConfidentialityProtection.What does giving consent mean?Once you understand what the frozen tumor sample donation is, and you aresatisfied with the answers to your questions and ready to express your will todonate, you should give your written consent by signing this form. This process isknown as informed consent.Who performs this optional donation procedure?The optional donation procedure may be conducted by any of the research sitesparticipating in the APHINITY study and which have the necessary resources tocollect, freeze and store tumor samples until they are moved to the study SampleRepository (i.e., biological materials bank) supervised by BIG and carried out byStudy Monitors and/or Roche’s subsidiary staff on behalf of BIG and ROCHE.Is there any risk in the donation of a frozen tumor sample?The sample BIG and Roche request is a residual sample; this means, a samplethat could not be used to establish your diagnosis or treatment. For this purpose,Version 1.0 in Spanish dated November 10, 2011, adapted from version 1 in English dated September 20,2011 (Agencia Médica/HS) 2
  • Protocol BO25126 CRTN 232448José Zorrilla Silvera, M.D.Centro de Investigación Clínica Trujillo EIRL – Clínica Peruano Americanaanother sample will be stored in Centro de Investigación Clínica Trujillo EIRL –Clínica Peruano Americana and will be used for this purpose.Is there any cost for me to participate in the study?There are no additional costs.Voluntary Participation:The consent for the donation of a frozen tumor sample is voluntary and you willhave enough time to decide whether or not to donate. If you do not accept, thisdecision will not affect your medical care or the benefits you currently have. Atany moment, without any reason, you will be able to request your sample to notbe used for research purposes anymore. Under no circumstances, this decisionwill affect the subsequent treatment or the relation with your doctor or the stafffrom Centro de Investigación Clínica Trujillo EIRL – Clínica Peruano Americana.If you withdraw your consent, your frozen tumor sample could be sent to Centrode Investigación Clínica Trujillo EIRL – Clínica Peruano Americana. where youare treated or it may be destroyed if you request so, provided that it has not beenpreviously used for or subject to specific processes. This is because tumorindividual samples can not be recovered once they have been processed forlaboratory analysis.How do I benefit from donating a tumor sample?You should understand that your frozen tumor samples are collected for futurescientific researches. This means you will not obtain any personal benefit fromyour donation. In other words, the information obtained from this donation will notbe used to make decisions on diagnosis or therapies related to your personalcare.However, we expect that this research will increase our knowledge about breastcancer and on the way to carry out future clinical studies by using technologiesthat analyze genes active during breast cancer.This will allow us to improve the quality of treatment and, thus, to help otherpatients with breast cancer in the future.Will I be paid for participating in this study?You will not receive any payment for your participation in this study. Reasonabletravel expenses arising as a result of your participation in this study will bereimbursed. The study site will also be paid for the expenses to conduct thisstudy.Who will be able to access the medical information related to my tumorsample?If you agree to donate a frozen tumor sample, your privacy will be protected atany moment. We know that the information about you and your health isconfidential and we commit to protect the privacy of such information. All the dataVersion 1.0 in Spanish dated November 10, 2011, adapted from version 1 in English dated September 20,2011 (Agencia Médica/HS) 3 View slide
  • Protocol BO25126 CRTN 232448José Zorrilla Silvera, M.D.Centro de Investigación Clínica Trujillo EIRL – Clínica Peruano Americanacollected in relation to the frozen tumor sample (personal, clinical, economic dataor those data obtained from research on the tumor) will be used pursuant to thevalid national regulations on data protection and privacy. The regulations setforth that you should authorize us in written to use any information about yourhealth related to the frozen tumor sample for future scientific researches. Bysigning this consent form, you give the study doctor and staff authorization to usethis information and to share it with the Sponsor (F. Hoffmann-La Roche Ltd.,represented in Peru by Productos Roche Q.F.S.A.) and BIG. This permissiondoes not expire automatically on a certain date unless you decide to withdrawyour consent to use your tumor and/or your medical information.Besides, in the context of scientific collaboration with other research groups, yourmedical information and your frozen tumor samples may be shared withresearchers from other institutions/hospitals, laboratories, organizations orprivate partners, which may be located in other countries or continents. However,you will not be identified by name, address, telephone number or otherinformation which may lead to directly identify you (i.e., your social securitynumber). Your data will be coded and your identity will not be revealed to thirdparties. The information related to the code will be kept in a safe place and onlystudy staff will be able to access to it.Reports or publications about the scientific researches conducted on your tumorsamples will not reveal your identity either.By signing this consent, you accept that the coded information about your frozentumor sample will be used in any of the following manners: - Storage and electronic analysis to interpret the results of scientific research - Publication of the results obtained in the scientific research - Shared use of your sample in researches of other universities, academic organizations or institutions, in order to better understand the human biology or to develop clinical studies. - Shared use of your sample with other BIG’s members, in the country where you receive treatment or in other countries. If the information is sent to other country, your data will keep the same protection degree, as per the local regulation. - Collaboration with other investigators to use the information related to your health and coded genomic data in secondary research projects. These projects may be focused on the breast cancer study or not. This means that your data may be used to study the existing differences between several cancers. It is likely that you will not have access to the results of this analysis.You are entitled to ask for your personal information and to modify it if its contentis inaccurate.Version 1.0 in Spanish dated November 10, 2011, adapted from version 1 in English dated September 20,2011 (Agencia Médica/HS) 4 View slide
  • Protocol BO25126 CRTN 232448José Zorrilla Silvera, M.D.Centro de Investigación Clínica Trujillo EIRL – Clínica Peruano AmericanaExplanation: your coded personal information (that means, replacing your nameand any other data that may identify you with a code), collected to the momentyou withdraw your consent will continue to be used as a study data if appropriatefrom the scientific point of view.What will happen with my tumor sample?Your frozen tumor sample will be stored safely in a Study Sample Repository,labeled with a single numeric code, as per the applicable legislation, and as longas you do not request to return it to the Centro de Investigación Clínica TrujilloEIRL – Clínica Peruano Americana, where you receive treatment or you requestto destroy it.The frozen tumor samples stored in the Study Sample Bank may be available inthe future for scientific investigators to improve the understanding and the breastcancer treatment. These investigators will require an academic investigatorscommittee, on behalf of the medical teams participating in the APHINITY study,to approve their scientific research. Any future scientific research using yourfrozen tumor sample will only be conducted with the approval of Centro deInvestigación Clínica Trujillo EIRL – Clínica Peruano Americana.The proposed research may lead to findings obtained, among other reasons,thanks to your frozen tumor sample stored in the Study Sample Repository, andthe company will be entitled to claim the ownership of those findings. You will nothave any right to claim any portion of the profits that may be obtained from theresearches conducted on your frozen tumor sample. As a research participant,you accept to renounce to all the ownership rights on findings arising from theuse of your clinical data and future researches conducted on the tumor sample.If you agree to donate your frozen tumor sample, you will be given a copy of thisinformed consent form about the optional donation of frozen tumor sample.My signature below means that: - I have received all the corresponding information about the optional donation of the frozen tumor sample, I have had the chance to make questions and enough time to think about my participation in the study - I have been given a copy of the informed consent form about the optional donation of the frozen tumor sample - I accept to donate my frozen tumor sample and allow the access to my other medical data as stated herein. I understand that all my medical data to be used in future scientific researches will be used pursuant to the regulations in force about data protection. - I understand that other investigators outside F. Hoffmann-La Roche Ltd., represented in Peru by Productos Roche Q.F.S.A. / Breast International Group, including other investigators who work for local or foreignVersion 1.0 in Spanish dated November 10, 2011, adapted from version 1 in English dated September 20,2011 (Agencia Médica/HS) 5
  • Protocol BO25126 CRTN 232448José Zorrilla Silvera, M.D.Centro de Investigación Clínica Trujillo EIRL – Clínica Peruano Americana commercial companies, may conduct some of the future scientific researches. - My participation is completely voluntary and I have the right to withdraw my consent at any moment without any reason. This decision will not affect the relation with my doctor.Version 1.0 in Spanish dated November 10, 2011, adapted from version 1 in English dated September 20,2011 (Agencia Médica/HS) 6
  • Protocol BO25126 CRTN 232448José Zorrilla Silvera, M.D.Centro de Investigación Clínica Trujillo EIRL – Clínica Peruano AmericanaPatient’s print Patient’s National Patient’s Date of Signature Time ofname Identity Card No. Signature SignatureWitness’ Witness’ Witness’ Witness’ Date of Time ofprint name National Relationship to Signature Signature Signature Identity Patient Card No.I, the undersigned, assigned investigator/staff member for the procedure, haveorally provided all the information corresponding to the optional donation, I haveprovided a copy of the informed consent form about the optional donation offrozen tumor tissue, I have answered all the additional concerns and I have notcoerced the patient to influence his/her decision.Investigator/Designee’s National Identity Signature of Date of Time ofSignature (Print name) Card No. of person Signature Signature person conducting conducting explanation of explanation of informed consent informed consentVersion 1.0 in Spanish dated November 10, 2011, adapted from version 1 in English dated September 20,2011 (Agencia Médica/HS) 7