Declaration of Consent
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- Bennett Glenn
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1 First Name,Surname Order: Date of Birth: female. male. Address: This document is given to the patient by the responsible medical person (in accordance with the German Gene Diagnostics Act - GenDG) before taking the sample. Stamp and signature of responsible medical personnel: Declaration of Consent For a genetic investigation (in accordance with the German Gene Diagnostics Act - GenDG) and implementation of a scientific study The question underlying the genetic investigation: With my signature I hereby confirm that I agree to the implementation of a genetic investigation by ALACRIS Theranostics GmbH and the taking of blood/tissue samples for this purpose by Mr./Ms (responsible medical person, in accordance with the GenDG). Furthermore, with my signature I agree that the results of the genetic testing are also used for scientific purposes, which aim to develop individualised treatments for tumours in light of genomic and tumour information.
2 a) Clarification I have been informed about the implementation and scope of the genetic testing and the possible results-based therapeutic options, as well as the risks associated with taking blood/tissue samples (my signature on the separate information sheet confirms this). The information given to me includes, in particular, the following points: - Risks of taking blood and tissue samples - Nature, significance and implications of genetic testing - Purpose, type, extent, validity, and limits of the achievable results of genetic testing - Possibility of adverse findings - Novelty of genetic testing - Possibility of the occurrence of previously unknown risks - Possibility of diagnostic or therapeutic deficits due to technical malfunctions in the context of genetic testing - Use and destruction of the test results and genetic sample b) Implementation and scope of genetic testing The genetic study is based solely on the above question and does not serve the purpose of obtaining knowledge about the presence of any other diseases or genetic characteristics. The use and storage of samples and test results were fully explained to me fully. I am also informed that the findings from the genetic study will be utilised in a scientific study that aims to develop individualised treatments for tumours in light of genomic and tumour information.
3 c) Medical Confidentiality The information given by me, as well as all test results are subject to medical confidentiality and will not be circulated to others (including other doctors) without my express written consent. d) Voluntary/Right of withdrawal I am aware that my participation in this study is voluntary and I may withdraw my consent at any time. e) Right to ignorance I am aware that I have a right not to know, including the right not to take the examination results or parts thereof, for knowledge, but instead allow them to be destroyed. Following being given information on the project, I acknowledge I had sufficient time to think about my decision to provide consent. I also had the opportunity to ask additional questions.
4 Data Privacy Agreement gem. 4 under the German Federal Data Protection Act (BDSG) With my signature, I hereby agree that my personal data for the purpose of e.g. creating an invoice for fees and the collection of the debt of, are used. I further declare that I agree to the results of the genome research being used for scientific purposes, which aim to develop individualised treatments for tumours in light of genomic and tumour information. I am aware that I can withdraw my consent at any time in the future.
5 Release of medical confidentiality For the purpose of carrying out genetic testing and the implementation of a scientific study on the development of individualised treatment of tumour diseases, I release the responsible person, Mr/Ms of his/her duty of medical confidentiality in relation to ALACRIS Theranostics GmbH. ALACRIS Theranostics GmbH in turn, is legally obliged to maintain confidentiality and to disclose the results of genetic testing exclusively to the responsible medical person who will tell me the results.
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