Mathematical Algorithmic Optimization - Otto-von-Guericke-University Magdeburg

 
 
 
 
 
 
 
 

MODEST and isitFlutter - Compliance with Ethics Requirements

General information

Our research involves data. Both ERC Grants have undergone a thorough Ethics Assessment Procedure by the European Union. The Ethics Assessment Panel of the ERC has validated compliance of our study design and data handling with the strict European guidelines. The review of the ERC PoC project isitFlutter is ongoing.

As part of these ethical assessments the collection and handling of personal data has been approved by the Data Protection Officer Rita Freudenberg from the Otto-von-Guericke-Universitat Magdeburg. The document confirms that the implemented data protection procedures comply with national and EU legislation.

All data (measurement data, parameter values corresponding to mathematical models and relevant data for training aspects) that is being used and stored within MODEST is necessary for either the calibration of mathematical models or for designing new training strategies. All data can and will without exception be pseudonymized and does not contain sensitive, compromising information. All data will be stored a maximum of 10 years after the end of the MODEST project. It will be treated according to data collection recommendations and practices at the Otto-von-Guericke Universitat Magdeburg. In all cases explicit informed consent of patients or participants will be given and only in exceptional cases we will apply to the University hospitals’ ethics committees for retrospective use of data, such as the data that has already been used for our published study.

General Comments concerning Informed Consent

All patients under treatment for cardiac arrhythmia at the University Hospital in Heidelberg and under treatment for blood cancer at the University Hospital in Magdeburg will be considered for inclusion, if informed consent is given. No additional means for identification or recruitment will be applied.

We will follow the principles of “Informed Consent” as presented, e.g., by the Code of Conduct from the American Psychological Association. These principles require psychologists to inform participants about

We will use prospective informed consent when possible. In addition, every patient at the University Hospital in Magdeburg signs “Allgemeine Vertragsbedingungen”, a general agreement between hospital and patient. Article §16 (5) reads (own translation from German): Non-personal, pseudonymized (in particular statistic) data can be used for scientific research, such as dissertations and habilitations. It will be guaranteed that from these data no inference on particular natural persons is possible and a link to a person can only be made with a disproportionally high effort.

Detailed information for specific studies and Informed Consent documents
At this place we will provide more detailed information on specific studies within isitFlutter and/or MODEST. In particular, download links for informed consent documents in German and English will be available.
Last Modification: 2016-08-05 - Contact Person: Sebastian Sager - Impressum