• medical professionals
• Legal and ethical
• Clinical Trials
• Consent form information
• Molecular biology
• Ontology
• In Silico Oncology
• Knowledge Discovery tools
• Kids

• Main menu
• ACGT for you
• General Information
• User information
• News
• Consortium
• Documents
• Join us
• Contact
• FAQ
•  

ACGT Newsletter

View Summer 2010 Issue

If you want to subscribe to the ACGT newsletter, please send us an email.

• The general terms document is common for all the parties involved in the ACGT project and, more specifically, in the patient's data processing (the patient, the physician, the hospital/investigator and the researcher). Indeed, we have thought easier to have a common text for all which the consent forms refer to.
• The consent forms, for its part, will, first of all, explain the purpose of the research project ACGT to the patient and will confirm some substantial principles to the concerned party and referring to the general terms.

General terms:

The purpose of the general terms document is to give a common document for all the parties involved in the data processing within the ACGT project (patient, hospital/investigator, physician, researcher, etc...).

In its preamble, the document explains the project which consists mainly in an exchange of information between physician and researchers. It gives the opportunity to researchers to use medical data for their research. They take for their part to send back the result to the physician if allowed by the patient.

In respect to the patient's privacy, we precisely refer to the Directive 95/46/EC which is the basis for the protection of individuals with regard to the processing of personal data.

ACGT sets also a framework to achieve this privacy. This framework consists in the transfer of the patient's medical data to the researcher after a processing of pseudonymization which is the replacement of the patient's name and other characteristics by a label. By this pseudonymization, the researcher won't be able to connect the medical information to the patient. To secure that, a first pseudonymization will be made by the hospital/investigator itself and the second one will be made by a totally independent third party, called trusted third party (TTP), directly or through a dedicated tool hosted by the hospital/investigator. This double pseudonymization will make impossible for the researcher to find whom the medical information is related to.

However and to allow a feed back of the result of the research to the patient, the TTP will have the ability and power to reconnect this result to the label given by the hospital/investigator at the beginning of the processing. After this "depseudonomization", the data will be sent to the hospital/investigator to allow the definitive reconnection to the patient's data. We remind that this "feed back" processing is subject to the patient authorization. If the patient doesn't allow that, it won't be made.

In accordance to the Directive 95/46/EC, the processing of the data will be made under the responsibility of a person (natural or legal person) who is the hospital or investigator (only in United Kingdom).

This person is in charge of the information to the patient about his medical data processing (including the pseudonymization). However and to allow the patient to have a direct contact with the data controller, this last one charges the patient's attending physician to be its representative towards the patient who is also called data subject in accordance to the Directive 95/46/EC.

The information given to the patient will also consists in giving the rights of the patients:

• the patient is always free to refuse his data processing and to withdraw his former consent without any motivation. In this last case, the data which has been already pseudonymized will be totally anonymized by the TTP what means that the key used for the pseudonymization will be erased. Those anonymized data will be used but without any possibility to connect them to the patient anymore.
• If the data are not yet pseudonymized, they will be erased without any further processing.
• the patient has the right to access to its own personal data;
• the patient has the right to correct the data. That means the patient can ask for the correction of his data if there's an inaccuracy. The modification will be done after a discussion with his attending physician to control if there's a real inaccuracy. Indeed, the patient may believe there's a inaccuracy what is not in reality. Inaccuracy means that the data doesn't reflect the reality, is not correct. It's objective fact and not a subjective one.

The consents form

In the context of this explanatory document, we'll only explain the patient's consent form.

In many countries in Europe, the child under 18 year old cannot contract by himself except for some special matters. In this context of incapacity, the child will be represented by someone who, usually, is his parents. The same situation exists with the under disability patient.

In accordance with those situation, there are two different patient's consent forms and a minor's agreement. This last document is used to inform a minor - who is capable to understand the explanation - about the processing and his right to maintain or withdraw the consent given by his representative as he gets the age of 18 or the majority.

The first part of the consent form is the explanation of the ACGT project. It's an ethic part.

The second part, which is more a legal one, reminds the patient's rights as explained in the general terms document and gives explanation about some specific points:

• about genetic information: if the genetic data cannot be disconnect from information concerning the patient's relatives which are parents and/or children, the patient has the opportunity to allow the attending physician to disclose the information in the way to request the close relatives for the processing of their data. Indeed, by the fact that the patient's genetic data cannot be disconnect from his close relatives' data, such request is needed.
• The patient can also refuse/accept that his DNA material is analyzed within the ACGT project.
• About the processing and the pseudonymization (see above);
• About the possibility of feed back (see above).