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11,000 patients make their healthcare data available for research in SMITH

Broad Consent sets important milestone in the networking of research and healthcare 

In everyday clinical practice, large amounts of healthcare data are routinely generated. This data is of great interest for medical research. It can, for example, help researchers to better understand disease progression and thus develop more targeted treatments. Patient consent is required before data from routine care can be used for this purpose. Since the specific research objective is usually not yet known at the time of consent, the Medical Informatics Initiative (MII) has drafted a Broad Consent and coordinated it at the national level.

In the SMITH Consortium, the number of Broad Consents is currently progressing. Already 11,000 patients have provided their healthcare data for research at four of the seven SMITH university medical sites to date. Three sites are currently in the pilot phase and will begin obtaining patient consents thereafter as well.

Patient self-determination first and foremost

The Broad Consent allows patients to decide whether they want to make their patient data, health insurance data and/or biomaterial available for research. They are also free to decide whether they want to be contacted again. This would be the case if, for example, important results were found through the analysis of their medical data or if participants were sought for clinical trials. The identification of the data for these purposes can only be done by an independent trustee. Researchers or other third parties have no access to personally identifying data. Patient consent is valid for five years and can be informally revoked at any time.

When obtaining patient consent, it is particularly important to ensure that patients make an informed decision. For this reason, they have the opportunity to obtain comprehensive information about MII and Broad Consent after admission to the hospital with flyers, posters and an explanatory film already in the waiting area. During their hospital stay, patients are then approached by trained staff. In a conversation, the specialist staff explain to them in detail how their pseudonymized healthcare data will be used. After the educational talk, the consent form can be filled out.

Targeted medical research for better treatments becomes possible

The Broad Consent is the legal basis for allowing medical data to be used not only for hospital treatment but also for research. This enables researchers to identify suitable patients, for example, as part of feasibility studies in preparation for a clinical trial. Current research projects analyze certain laboratory parameters, among other things, in order to derive indications of disease risks. This can be used in the hospital during treatment to implement suitable measures at an early stage to prevent an impending deterioration in health. By agreeing to the use of their healthcare data, patients contribute to targeted medical research, more precise diagnoses and better treatments.