Can doctors do biomedical research?
The container with the frozen samples of blood and other body fluids is scanned in Bern's Inselspital before it is automatically removed. | Image: InselGruppe / Pascal Gugler
On the last day of the 2017 spring session, the Vaudois SP National Councilor Rebecca Ruiz called for the creation of a biobank law by motion. “Biobanks, in which data and samples from the treatment of patients are collected and evaluated, are rapidly gaining in importance,” argues Ruiz. "But the current law only covers them incompletely." 23 parliamentarians support the initiative.
The reason for this was the consultation process on the “general consent” that the Academy of Medical Sciences and Swissethics worked out at the end of March: If patients sign this form in the hospital, their data and samples can be used for future, as yet unknown research projects. University hospitals have been working with such general declarations of consent for a long time, although these differ from canton to canton. With the general consent, a nationwide standardized form is available for the first time.
More data security required
What makes science happy, patient protection views with concern. "It is not acceptable that such an important area of biomedical research and the handling of digitized patient data and samples are based on an incomplete legal basis," criticizes Bern law professor Franziska Sprecher, who represents the patient protection organization SPO. Data security is insufficiently guaranteed in the hospitals, for example, and in the event of a data leak the patient would be quite lonely.
Why is general consent so important for biomedical research at all? Laboratory doctor and pioneer Vincent Mooser, who has been running a biobank with blood samples at the University Hospital Lausanne (CHUV) since 2013, explains: "To achieve success in the field of personalized medicine, you need data from a very, very large number of people." Mooser cites the CoLaus study, which was started in Lausanne in 2003 with the aim of identifying cardiovascular risk factors, as an example. The Lausanne cohort with over 6000 patients is a success, but the CHUV has to cooperate with other hospitals for further results.
Research at an international level
The general consent makes it possible to exchange data - within Switzerland, but also with foreign laboratories. “We will do research on a completely different scale,” says Mooser. That is essential in order to remain internationally competitive. Other countries such as the USA, Great Britain, China or India have long since started using big data for medicine. Incidentally, the general consent is not a blank check: "Researchers need the approval of the ethics committee for every project," emphasizes Mooser.
The Swiss show hardly any reluctance to donate their health data for research: at the CHUV, for example, three out of four patients agree, even if the entire genome is analyzed. The proportion is even higher at the University Hospital Basel. To date, over 27,000 general declarations of consent have been collected in Lausanne. For Vincent Mooser, it goes without saying that the relevant data and samples are protected according to the highest security standards.
The office of the Swiss Biobanking Platform, to which the major Swiss biobanks have come together, is also located at the CHUV. The website welcomes Rebecca Ruiz's motion to create a biobank law. For now, the network intends to submit to the Taipei Declaration, which the World Medical Association adopted in 2016. The principles for the operation of biobanks are laid down in it. This commitment is a "strong signal" for law professor Sprecher, but she demands even more: the declaration must be included in the professional code of the medical profession.
Irène Dietschi is a freelance science journalist in Olten.
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