Information about the CONCOR registration:
Every year in the Netherlands around 1500 children are born with congenital heart disease. The past 40 years, life expectancy of patients with congenital heart disease greatly improved in particular by developments in the field of cardiac surgery. Despite the fact that the majority of these patients had surgery at a young age, remains in many cases life-checking with the cardiologist is necessary because in some patients long-term complications may arise.
It is unknown how many adult patients with congenital heart disease exactly in the Netherlands and the overseas territories of the (United) Kingdom of the Netherlands are born. We also know of many - mostly operated - defects not how the course will be long term. The Dutch Heart Foundation and the Netherlands Heart Institute have jointly initiated a registry and DNA bank of adults with congenital heart disease. The CONCOR-registration is set up to identify how many adult patients with congenital heart disease in the Netherlands live and what problems may arise in the longer term. By existing knowledge and expertise together to care for these patients improve in future.
The CONCOR registration information like name, gender, birth date, center for the last time you were treated and data on diagnoses and interventions (eg surgery) included. You can participate in the CONCOR-registration by the consent form to sign and send it to us.
If you participate in the CONCOR registration is important to your health information to be obtained from the center (and cardiologist) where the last was under control. To be able to retrieve this information, please sign the consent form.
Your data is secure in accordance with the provisions of the Data Protection Act. One of our researchnurses run - after written consent and after you have received your request for medical records - the data before and will be sent to the central point of storage to be coded ("encrypted"). With this encoding, the data can not be read and to interpret and reduction to the patient (you, in this case) is no longer possible. The data is stored well protected. Your data is not accessible to unauthorized persons.
To protect the privacy of this data is a record made. Here are your rights and our duties are described. You can see these rules as you would like us to. There is also a - previously mentioned - Monitoring Committee appointed to oversee the registration and the proper observance of the regulations.
Information about the DNA bank CONCOR:
In recent years, interest in genetic causes of congenital heart defects increased. The DNA is the substance in the body where the genetics are recorded. This DNA is present in all cells of the body and potentially the same everywhere. With modern techniques it is possible to search for the genetic basis of congenital heart defects. Results from these studies may have clinical consequences in the future: -Knowledge of the genetic causes of congenital heart defects may result in patients with congenital heart disease who have a child to get better informed about the risk of repetition ("genetic counseling"). -Possibly the knowledge of the genetic background of congenital heart defects in the future lead to changes in treatment of patients with congenital heart disease
To research into the genetic backgrounds in large groups of patients with a congenital heart defect, the Netherlands Heart Institute and the Dutch Heart Foundation (NHS) took the initiative to establish a national DNA bank (CONCOR-DNA bank).
Purpose of the CONCOR-DNA-bank is:
Facilitating scientific research into the genetic backgrounds of congenital heart defects. In this bank will DNA of patients who have given permission to be saved. To this end, one tube (total 10 ml) decreased blood, then by editing the DNA isolated and stored. Participation in the CONCOR- DNA-bank is only possible if the patient also has given permission for participation in the CONCOR-registration.
This DNA can – if for permission is obtained from the Netherlands Heart Institue and an independent Commission of supervision (Commission CONCOR) – are used for scientific genetic investigation of congenital heart defects. Research will focus on the possible relationship between clinical data/diagnoses (such as included in the CONCOR-registration) and specific hereditary characteristics (by examining the DNA). There will be only research carried out into the causes of congenital heart defects and not to other hereditary diseases or properties. Your data in the CONCOR-registration and your blood sample are well protected and for unauthorized not accessible.
Your DNA can be used for scientific research. Sometimes during this kind of DNA investigations results found that might be important for your health. This means that you would have a clear advance medical treatment by this finding. The include results associated with your heart condition, but also to additional casual results that have nothing to do with the heart condition. In some cases, there may be results also emerge that are important for the health of your family members and/or (future) children and which are extremely important to provide good medical care.
It is also possible that a variation is found in your DNA, which is not clear whether this has any meaning and whether it relates to the appearance of your heart condition. It may be scientifically desirable here to do further research. We ask you whether you agree that you will by your treating cardiologist approached to participate in further research. If the results of DNA testing warrant, this may mean that you learn more about variations in your DNA. For clarity, when you consent to be contacted, you have no permission for further investigation. You will only consent to be contacted tomorrow, so the method of further research could be explained to you
Apart from the above information on variations in the DNA, personal, individual research results are not communicated.
Your consent to participate in the DNA bank at any time. You should discuss with the CONCOR Project submissions. Your DNA will be destroyed as soon as possible. We will in these cases is that of consent for participation in the CONCOR-registration is not revoked. Should you for your cooperation with the CONCOR to terminate registration you can also say the CONCOR Project. Your information will then CONCOR from the registration removed.
For this DNA bank is a privacy regulations designed to complement the privacy regulations, which the CONCOR-registration is available. Here are your rights and our duties are described. You can see these rules if you would like us to. CONCOR The Commission shall ensure that these regulations are complied with by us.
If you require a consultation with an independent (not involved in the project) doctor, please contact Mw.dr. M. Vis, cardiologist, Academic Medical Centre, Amsterdam, phone: 020-5628947
To the decrease of blood is no health risk. Therefore, the AMC Medical Ethical Committee granted that no research for this project insurance needs to be closed.