Gesine Richter receives AKEK Research Award 2023
Dr. Gesine Richter has been awarded the AKEK Research Prize 2023. The prize is presented by the German Association of Medical Ethics Committees (AKEK) in recognition of Richter’s innovative research on the topic of medical data donation. Her work sheds light on the conditions under which individuals are willing to donate their medical treatment data for research purposes, without explicit consent.
When patients participate in research projects, they must be informed about the purpose, benefits, and risks and asked for their consent. This applies not only to clinical trials related to therapy but also to observational studies that collect patient data and biomaterials such as blood or urine. An extended form of consent is the so-called “broad consent.” This allows patients to agree that data generated during a hospital stay and leftover biomaterials, such as tissue from surgery, can be used for research purposes without knowing about a specific research project at the time of obtaining consent. The University Medical Center Schleswig-Holstein (Campus Kiel), where Dr. Gesine Richter works, introduced this broad consent approach in 2015.
High potential for using healthcare data in research
With the advent of electronic medical records, medical data is now available in various contexts. The integration and analysis of these data have enormous potential to advance healthcare through research, as highlighted by the current COVID-19 pandemic. However, the barriers to make use of these data are significant.
As part of her doctoral thesis, Gesine Richter investigated people’s willingness to participate in research projects without explicit consent. This means that patient data and biomaterials could be used for research purposes without their explicit consent (referred to as “data donation”), but with the right to opt-out. This concept is also being discussed in the context of organ donation in Germany.
German citizens hold a positive view on data donation
Richter’s research shows that the majority of people have a positive view of data donation. Many patients are willing to give back if they themselves have benefited from research. It is seen as a duty of every citizen to contribute to medical progress through the use of their own data. While there is a positive attitude towards data use by universities, the use of data by commercially-oriented research companies is viewed critically. Concerns exist regarding inadequate data protection and the fear that companies may profit from the data. Accordingly, the acceptance of participation without explicit consent seems to be linked to clear legal regulations on data protection.
Richter concludes that “data donation for medical research, implemented as a combination of a legal entitlement and an easy-to-exercise opt-out right, is widely supported by German patients.” Regarding the need for legal regulation of data donation, she states: “The population’s attitude towards data donation for medical research depends crucially on how relevant they consider this research and what concerns they have about data security and control. However, data use without explicit consent does not mean the abandonment of the informed consent paradigm. A discussion is needed on how the process of providing information on increasingly complex issues can be redesigned.”
To enable citizens to make an informed decision about data donation, all parties involved in research must work together to improve people’s health and research data literacy. It must be integrated into existing efforts to increase health literacy in Germany.
The AKEK Research Prize was awarded during this year’s AKEK Summer Conference on June 15, 2023. The doctoral thesis was conducted at the Institute of Experimental Medicine at the Christian-Albrechts-University of Kiel and is entitled “Empirical Accompaniment of Participation in Medical Research Without Explicit Consent, Involving the Concept of Data Donation.” At the DZL, Richter works in the area of quality management of the Biobank platform and advises DZL researchers on ethical issues.
AKEK Research Award [German]
Press release TMF [German]
Dissertation Dr. Gesine Richter: “Empirische Begleitung der einwilligungsfreien Teilnahme an medizinischer Forschung unter Einbeziehung des Begriffs der Datenspende” [in German]