How To Register Your Child For A Heart Defect Survey In Germany
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- Angela Blake
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1 Information for parents/legal guardians including declaration of consent to the study Information for parents/legal guardians Please read this information carefully. Your consulting physician will also talk to you directly about this study. This will provide you the opportunity to clarify questions and to receive additional information. Dear parents, although heart defects are the most frequent congenital malformations, reliable data concerning the actual number of congenital cardiac malformations as well as concerning the incidence of single heart defects is lacking in Germany so far. That is why the Competence Network for Congenital Heart Defects is carrying out a scientific investigation. The survey aims at the area-wide and complete registration of all newborns with a congenital heart defect within a cohort. Thus, assessments can be made with respect to the disease s incidence, the character of heart defects and regional distributions. Apart from yielding scientific information about the actual situation, this population-based data shall also be used for planning, documenting and promoting up-to-date and patient-suited care. The survey will be nationwide; numerous paediatric cardiologist clinics and licensed paediatric cardiologists are participating. The data will be collected in the National Registry for congenital heart defects (registered association), Berlin, which is responsible for storing data in accordance with data privacy regulations and performing anonymous analyses. We would like to ask you to register your child for this new survey investigating the incidence of congenital heart defects in newborns in Germany. For this purpose, your physician will record the exact diagnosis of the heart defect and other possible congenital diseases. In addition, we require a few data concerning the pregnancy and birth, your age at delivery and your child s sex, nationality, place of birth and residence. Please give your consent to this survey by marking the first option on the form (PAN with a cross. If you also agree to the possibility that the National Registry for congenital heart defects (registered association) might directly contact you, in case further scientific and sociomedical interviews are required (e. g. for a study succeeding this survey or one concerning the condition of children with heart defects), please give your consent for this, too, by marking also the second option on the form with a cross. page 1 of 5
2 Conditions for participation Participation in the survey is voluntary. Equally, already given consent can be withdrawn without giving reasons at any time. As a matter of course, no disadvantages will result in case you deny to participate. Neither you nor the clinic nor the health insurance company will have to incur any additional costs due to your participation in this survey. In the following, we will give you further detailed information on data security and data management: The National Registry for congenital heart defects (registered association) is responsible for both storage and analysis of the collected data; all regulations of the Data Protection Act are met. The Berlin official for data protection and freedom of information (as well as the data protection officials of all German federal states) has agreed to the proceeding described in the following. Data acquisition The collection of personal data is necessary to guarantee high quality of the collection, particularly to avoid double registrations, and for further interviews at a later time. For this purpose, a written consent is required. If you give this consent, your consulting physician will document personal data (first name and surname, date of birth, place of birth and residence, sex, nationality, address and contact data) and medical data (data on both birth and pregnancy, diagnose(s) of the congenital heart defect and possible accompanying diseases) of your child. If you do not consent to the registration and storage of the aforementioned data, only sex, month and year of birth, federal state of birth and of residence and the diagnosis of the heart defect are passed on in anonymised form. Transmission and storage of data The consent signed by you remains with the physician who transfers your child s data to us. Personal data and contact data are stored in a patient list, for which the National Registry for congenital heart defects (registered association) is responsible. nly selected members of the study management have access to this list. The medical data including the diagnosis of the heart defect, potentially existing other diseases of your child and data concerning pregnancy and birth, sex, nationality, residence and place of birth are stored separately in a different database, which includes your child s name and date of birth only in form of an encrypted code. nly a person that is especially authorised and sworn to secrecy by the National Registry for congenital heart defects has access to the key that is needed to reassign data from this registry database to your child s name for reasons of data administration or to establish contact. page 2 of 5
3 Data evaluation nly collaborators of the study have access to your child s data. These persons are sworn to secrecy. External access to the data is denied as well as the use by third parties. The data is evaluated and published exclusively anonymously; it will not be possible to associate you or your child with any of the results. Data management and erasure The data stored in the patient list (see above) and the registry database is saved permanently in the Registry. n completion of the 18 th year of life at the latest, your child will be asked for his or her consent to the data storage. You can object to the processing of the data at any time. In this case, no more data is collected and the personal data of your child including the corresponding key is deleted, i. e. destructed. At your request, the data stored within the scope of this survey will be communicated to you. If you have further questions, please address the consulting physician or directly contact Dr. Gerda Schwedler Competence Network for Congenital Heart Defects Augustenburger Platz Berlin Phone: Fax: schwedler@kompetenznetz-ahf.de If you have read the previous details, found the content clearly understandable and agree to the participation in this survey, we would like to ask you to give us your consent to the individual-related registration by signing the enclosed declaration of consent and by taking part in the survey. We wish you and your child all the best! page 3 of 5
4 Information for parents/legal guardians and declaration of consent to the study Declaration of consent (to remain with the patient) I have been informed about the content and intention of the survey concerning the prevalence of congenital heart defects in newborns in Germany. For this purpose, I have received an information sheet for parents/legal guardians, which I have understood; I was given enough opportunity to clarify the questions I had on this issue. Herewith I/we grant permission to the transfer and storage of personal data as described in the information sheet and to their anonymised evaluation (PAN. I/we agree to being approached by the National Registry for congenital heart defects (registered association) for further scientific studies patient s first name and surname date of birth (please use block letters) signature of parents/legal guardian signature/stamp of consulting physician page 4 of 5
5 Information for parents/legal guardians and declaration of consent to the study Declaration of consent (to remain with the physician) I have been informed about the content and intention of the survey concerning the prevalence of congenital heart defects in newborns in Germany. For this purpose, I have received an information sheet for parents/legal guardians, which I have understood; I was given enough opportunity to clarify the questions I had on this issue. Herewith I/we grant permission to the transfer and storage of personal data as described in the information sheet and to their anonymised evaluation (PAN. I/we agree to being approached by the National Registry for congenital heart defects (registered association) for further scientific studies patient s first name and surname date of birth (please use block letters) signature of parents/legal guardian signature/stamp of consulting physician page 5 of 5
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