MODEST and isitFlutter - Compliance with Ethics Requirements
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
- (1) the purpose of the research, expected duration, and procedures
The goal of this research project is to develop new decision support
approaches for clinical doctors, based on simulations of mathematical models that capture the most
important typical features of disease dynamics. The duration fluctuates from study to study, the whole project is set up to last 5 years.
- (2) their right to decline to participate and to withdraw from the research once participation has begun
Participating in this research study is completely voluntary. The patient can withdraw from participation at any
time, without consequences and without need for justification.
- (3) the foreseeable consequences of declining or withdrawing
In the case of withdrawal, all relevant
data will be deleted, unless the patient agrees that despite of his/her withdrawal past data may still be processed.
- (4) reasonably foreseeable factors that may be expected to influence their willingness to participate such as potential risks, discomfort, or adverse effects
No additional information will be stored, compared to standard treatment. Therefore there are
no risks involved.
- (5) any prospective research benefits
The data is used to check whether mathematical algorithms are able to find the correct diagnosis. Such
algorithms may in the future be used to support medical doctors in their decision making task. The same
mathematical models and algorithms may be used for the training of future medical doctors, just as flight
simulators are nowadays used for airplane pilots.
- (6) limits of confidentiality
All regulations concerning legal requirements concerning confidential medical communication and data
protection will be respected in this study, supervised by the data protection officer of the Otto-von-
Guericke University of Magdeburg and the Ethics Committee of the University Hospital in Heidelberg.
Only pseudonymized data will be communicated electronically.
No third party will get access to original medical records.
- (7) incentives for participation
Although it is unlikely that the patient can profit directly from the computer processing of
his or her data, as this is part of a long term research project, it may help to develop a better understanding
of underlying mechanisms and of decision support and training tools that will help future patients.
- (8) and whom to contact for questions about the research and research participants rights.
For specific questions feel free to contact Sebastian Sager or any other member of his research group.
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