C HUMAN G L D Dr. Klein, Dr. Rost and Colleagues Btest ... fileIn accordance with the guidelines of...
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In accordance with the guidelines of the German Commission on Genetic Diagnostics (GEKO) on the requirements for the content of patient information according to Paragraph 23, subparagraph 2, number 3 of the German Genetic Diagnostics Act for genetic analyses to clarify family relationships. The purpose of this information sheet is to provide you with comprehensive information about family relationship analyses and the associated legal requirements. The provision of information is obligatory according to the German Genetic Diagnostics Act and the guidelines of the GEKO. We there- fore ask you to read this sheet carefully and then to sign it. Please note that a signature is required from all persons (or their legal representatives) whose sample material is to be investigated. Should any questions or concerns arise from reading the information sheet, you can contact us by phone (+ 49.89.8955780) or email ([email protected]). Our specialists will be happy to give you further information. 1) Scientific background The Center for Human Genetics and Laboratory Diagnostics Dr. Klein, Dr. Rost and Colleagues conducts family relationship testing by the analysis of microsatellites (MS) in genetic material (DNA), which are recognized as evidence in forensic investigations and pedigree analyses worldwide. Microsatellites are regions of non-coding DNA comprising a variable number of repeats of a certain sequence motif, which can be found scattered over the whole genome. With the exception of gender, the examined DNA features do not allow any direct conclusions about personal characteristics or illnesses. The sole purpose of the investigation is to establish a family relationship. Every individual carries two copies (alleles) of these microsatellites (MS) in every nucleated cell. These MS may have different lengths depending on whet- her they originate from the father or mother. The pattern of lengths of multiple microsatellites is unique to each individual (except identical twins) and forms the so-called genetic fingerprint. Thus, the simultaneous analysis of several MS, the comparison of the patterns between different persons and the application of recognized biostatistical procedures can determine or exclude family relationships with a high degree of certainty. The significance of family relationship DNA analyses depends on the number of people examined. According to the guidelines of the German Commission on Genetic Diagnostics (GEKO), the child’s mother should only be excluded from the analysis when she is unavailable for examination. If no maternal material is available for a paternity test, a conclusion is still possible. However, this requires a greater investigative effort. 2) Examination procedure Two clearly labeled blood samples (at least 1 ml each) or two oral mucosa swabs are required from each person participating in the analysis. For rela- tionship tests, two samples are required from each person to enable an independent check of results. The samples must be taken and sent in for testing by a neutral, appropriately qualified person. Genomic DNA is isolated from the submitted sample and a minimum of 15 microsatellite systems are amplified by PCR. The length of the DNA frag- ments is determined by capillary electrophoresis and the probability of paternity or the degree of relationship calculated statistically. The results are usually available within 10-14 working days from receipt of the complete order. The report will be sent to the customer by post after receipt of payment, with copies to all persons tested if applicable. The result will not be communicated electronically or over the telephone for data protection reasons. Note: The sampling is done using standard medical procedures (venipuncture or oral mucosa swab), which present no significant health risks to the test participants. CENTER FOR HUMAN GENETICS AND L ABORATORY DIAGNOSTICS Dr. Klein, Dr. Rost and Colleagues 3) Consent The family relationship DNA analysis can only be performed when all people involved have consented in writing to the examination and the collection of the necessary genetic sample. To clarify the biological parents of a child, father, mother and the child have a mutual right to consent to a genetic family relationship analysis and to tolerate the collection of test material. This was laid down in 2008 by the “Claim to consent to a genetic examination to clarify natural parentage” (German Civil Code Section 1598a, Paragraph 1-4). A person who has consented to a genetic family relationship test and has provided a genetic sample is ent- itled to request access to the test report, or a copy of the report from the person requesting the relationship clarification. The family court deci- des disputes. Information and Consent for Family Relationship Testing Contact Specialists Tel. +49.89.895578-0 Christoph Marschall, Ph.D. Fax +49.89.895578-780 Christina Sofeso, M.Sc. Medical Directors Dr. Imma Rost Dr. Hanns-Georg Klein This form must be filled in by all test participants! B Key to symbols: F external examination Tel. +49.89.895578-0 Fax +49.89.895578-780 www.abstammungsanalyse.de Medical Directors Dr. med. Imma Rost Dr. med. Hanns-Georg Klein MVZ Martinsried GmbH Lochhamer Str. 29 82152 Martinsried D-PL-21356-01-00 CEO Benedikt von Braunmühl Dr. med. Hanns-Georg Klein District Court Munich Commercial register: 241161 Tax number: DE320949669 Version 15.2eng/11.06.2019 Molecular, Neuro, Metabolism genetcs Pharmacogenetcs Nutrigenetcs Relatonship Testng Cytogenetcs Reproducton Genetcs Immunobiology Clinical Chemistry Molecular Oncology Pathology Immunogenetcs Immunodeficiency Molecular Microbiology Virology
Transcript of C HUMAN G L D Dr. Klein, Dr. Rost and Colleagues Btest ... fileIn accordance with the guidelines of...
In accordance with the guidelines of the German Commission on Genetic Diagnostics (GEKO) on the requirements for the content of patient informationaccording to Paragraph 23, subparagraph 2, number 3 of the German Genetic Diagnostics Act for genetic analyses to clarify family relationships.
The purpose of this information sheet is to provide you with comprehensive information about family relationship analyses and the associated legalrequirements. The provision of information is obligatory according to the German Genetic Diagnostics Act and the guidelines of the GEKO. We there-fore ask you to read this sheet carefully and then to sign it. Please note that a signature is required from all persons (or their legal representatives)whose sample material is to be investigated. Should any questions or concerns arise from reading the information sheet, you can contact us by phone(+ 49.89.8955780) or email ([email protected]). Our specialists will be happy to give you further information.
1) Scientific background
The Center for Human Genetics and Laboratory Diagnostics Dr. Klein, Dr. Rost and Colleagues conducts family relationship testing by the analysis ofmicrosatellites (MS) in genetic material (DNA), which are recognized as evidence in forensic investigations and pedigree analyses worldwide.Microsatellites are regions of non-coding DNA comprising a variable number of repeats of a certain sequence motif, which can be found scattered overthe whole genome. With the exception of gender, the examined DNA features do not allow any direct conclusions about personal characteristics orillnesses. The sole purpose of the investigation is to establish a family relationship.
Every individual carries two copies (alleles) of these microsatellites (MS) in every nucleated cell. These MS may have different lengths depending on whet-her they originate from the father or mother. The pattern of lengths of multiple microsatellites is unique to each individual (except identical twins) andforms the so-called genetic fingerprint. Thus, the simultaneous analysis of several MS, the comparison of the patterns between different persons andthe application of recognized biostatistical procedures can determine or exclude family relationships with a high degree of certainty.
The significance of family relationship DNA analyses depends on the number of people examined. According to the guidelines of the GermanCommission on Genetic Diagnostics (GEKO), the child’s mother should only be excluded from the analysis when she is unavailable for examination. Ifno maternal material is available for a paternity test, a conclusion is still possible. However, this requires a greater investigative effort.
2) Examination procedure
Two clearly labeled blood samples (at least 1 ml each) or two oral mucosa swabs are required from each person participating in the analysis. For rela-tionship tests, two samples are required from each person to enable an independent check of results. The samples must be taken and sent in fortesting by a neutral, appropriately qualified person.
Genomic DNA is isolated from the submitted sample and a minimum of 15 microsatellite systems are amplified by PCR. The length of the DNA frag-ments is determined by capillary electrophoresis and the probability of paternity or the degree of relationship calculated statistically.
The results are usually available within 10-14 working days from receipt of the complete order. The report will be sent to the customer by post afterreceipt of payment, with copies to all persons tested if applicable. The result will not be communicated electronically or over the telephone for dataprotection reasons.
Note: The sampling is done using standard medical procedures (venipuncture or oral mucosa swab), which present no significant health risks to the testparticipants.
CENTER FOR HUMAN GENETICS AND LABORATORY DIAGNOSTICSDr. Klein, Dr. Rost and Colleagues
3) Consent
The family relationship DNA analysis can only be performed when all people involved have consented in writing to the examination and the collectionof the necessary genetic sample.
To clarify the biological parents of a child, father, mother and the child have a mutual right to consent to a genetic family relationship analysis and totolerate the collection of test material. This was laid down in 2008 by the “Claim to consent to a genetic examination to clarify natural parentage”(German Civil Code Section 1598a, Paragraph 1-4). A person who has consented to a genetic family relationship test and has provided a genetic sampleis ent- itled to request access to the test report, or a copy of the report from the person requesting the relationship clarification. The family court deci-des disputes.
Information and Consent for Family Relationship Testing
Contact Specialists Tel. +49.89.895578-0 Christoph Marschall, Ph.D. Fax +49.89.895578-780 Christina Sofeso, M.Sc.
Medical DirectorsDr. Imma RostDr. Hanns-Georg Klein
This form must be filled in by all test participants!B
Key to symbols: F external examination
Tel. +49.89.895578-0 Fax +49.89.895578-780www.abstammungsanalyse.de
Medical DirectorsDr. med. Imma RostDr. med. Hanns-Georg Klein
MVZ Martinsried GmbHLochhamer Str. 2982152 Martinsried
D-PL-21356-01-00
CEOBenedikt von BraunmühlDr. med. Hanns-Georg Klein
District Court MunichCommercial register: 241161Tax number: DE320949669
Version 15.2eng/11.06.2019
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4) Inclusion of people incapable of giving informed consent
In the case of a person unable to recognize the nature, significance and implications of genetic testing and hereafter express their will (e.g. minors,persons with intellectual disabilities), a relationship analysis may only be undertaken when the following conditions are met:
The investigation must be presented to that person in an appropriate manner so that it has been made as understandable as possible. The personmust not refuse to be included in the test or the sample collection.The legal representative (e.g. custodial parents, carers) of that person must have been previously informed about the test and must haveconsented in writing to both the test and sample collection.
Confirmation of information and declaration of consent
I hereby confirm that sufficient explanation has been given about- the purpose, nature, scope and significance of the planned family relationship test- the achievable results- possible health risks- the intended use of the genetic sample, as well as the test results.
I have been informed of my right, - to withdraw consent at any time - of my right not to acknowledge the result of the test or parts thereof but to have it destroyed.
I have been given a reasonable period of time to decide to consent.
For a person who is not legally competent, receipt of this information must be confirmed by the legal representative(s) stating his, her full name (incapital letters).
Person 1
____________ _______________________________________ _____________________________________________Date Name Consent for myself and if applicable my underage child
Person 2
____________ _______________________________________ _____________________________________________Date Name Consent for myself and if applicable my underage child
Person 3
____________ _______________________________________ _____________________________________________Date Name Consent for myself and if applicable my underage child
5) Withdrawal and right not to know
Each person has the right to withdraw consent to take part in the analysis and sample collection at any time, with effect for the future, either in writingor verbally to the Center for Human Genetics and Laboratory Diagnostics. Furthermore, each person has the right not to acknowledge the result orpart of it, and to request that it be destroyed.
6) Use of sample materials and the analysis result
The sample sent will be used exclusively for the family relationship analysis. After completion of the analysis (including if necessary a second indepen-dent check of results), the samples will be destroyed immediately, unless otherwise indicated.
In accordance with the stipulations of the German Genetic Diagnostics Act, test results will be stored for 30 years by the Center for Human Geneticsand Laboratory Diagnostics unless one of the parties involved has withdrawn consent or decided that the result must be destroyed.
CENTER FOR HUMAN GENETICS AND LABORATORY DIAGNOSTICSDr. Klein, Dr. Rost and Colleagues
Contact Specialists Tel. +49.89.895578-0 Christoph Marschall, Ph.D. Fax +49.89.895578-780 Christina Sofeso, M.Sc.
Medical DirectorsDr. Imma RostDr. Hanns-Georg Klein
This form must be filled in by all test participants! B
Tel. +49.89.895578-0 Fax +49.89.895578-780www.abstammungsanalyse.de
Medical DirectorsDr. med. Imma RostDr. med. Hanns-Georg Klein
MVZ Martinsried GmbHLochhamer Str. 2982152 Martinsried
D-PL-21356-01-00
CEOBenedikt von BraunmühlDr. med. Hanns-Georg Klein
District Court MunichCommercial register: 241161Tax number: DE320949669
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