The Value of Consent

The general consent form is in routine use in Swiss hospitals. By signing it, patients give permission for their health data and biological samples – such as blood or tissue – to be used for future research projects.

The decision on general consent is made on registration: patients accept or reject it. At the University Hospital Zurich, the form comes with the admission papers; at Balgrist University Hospital, it is part of a set of documents; and at the University Children’s Hospital Zurich, it is given to parents or caregivers.

Medical data and biological samples have long been more than just a byproduct of healthcare. These resources help us better understand diseases, compare treatments and improve care in a more targeted way. To achieve this, researchers need data sets with maximum detail. In this respect, the general consent is based on a simple principle: those who agree will make their data and samples available for research. However, for this consent form to be legally and ethically viable, it ends up as a complex legal document.

“In the 40-plus clinics of the University Hospital Zurich, issuing of the general consent documents is organised on a clinic-specific basis,” says Regina Grossmann, head of the hospital’s Clinical Trials Center. “The form is given out to virtually all in-patients and out-patients; the return rate for signed forms is around 70 percent, and sometimes even higher,” Grossmann adds.

As consent documents can quickly become time-consuming for hospital staff, the University Hospital Zurich wants them to be easily comprehensible. In a “patient and public involvement” approach, the hospital collaborated with patient representatives to develop videos and infographics that clearly explain what yes and no mean, and that saying no does not affect the treatment received. The University Hospital Zurich’s consent form is two pages long, and also has a QR code that links to a website with information. The University Hospital Zurich makes the form available in 15 languages.

At Balgrist University Hospital, outpatients and inpatients receive up to three documents, depending on their registration route: the registration form, a separate declaration of consent to the processing of personal data and the multi-page general consent form. Marie-Helene Suter, data protection officer at Balgrist Hospital, states: “The consent form has multiple pages for regulatory reasons.” Previous shorter versions no longer met data protection and ethics committee requirements. Consequently, the text was examined in-house and externally, and revised a year ago. Suter says that the process was complex: ethics, data protection and legal staff had to collate and approve the content together.

At the Balgrist, around 75 percent of patients sign the consent form. Marie-Helene Suter explains that language barriers are a more common reason for people not signing than objection to the forwarding of data: the text has difficult and legally complex content, which makes it inaccessible for some. However, legal precision is essential.

At the University Children’s Hospital Zurich, the situation is again different. Margarete von Wantoch, head of the Clinical Trial Unit, explains that young people aged 14 or over who are capable of judgement may give their own consent to research with minimal risk and minimal effort (e.g., surveys or observations). In all other cases, a legal representative must give consent. The general consent form is sent out with the appointment letter or handed out during the first visit. The two-page form explains details such as the purpose of the research, how data will be encrypted and kept confidential, that consent is voluntary, and how to withdraw it.

Von Wantoch says the return rate is around 70 percent. She points out that many forms are returned without an affirmative or negative response. There are no resources for systematic follow-up, and the issue arises at a sensitive time, she adds. In such a stressful situation, parents are not in the right frame of mind to tackle an abstract, legally binding document unrelated to healthcare.

The return of forms gives rise to a question: who gives consent – and who does not? After all, if consent is shaped by factors such as nationality, gender or age, conclusions cannot be adequately applied to the entire population. Regina Grossmann describes a cluster analysis at the University Hospital Zurich, which indicated that younger women tend to refuse consent. To check whether this pattern occurred only locally or across Switzerland, a cross-site project with multiple university hospitals is planned; funding from the Swiss National Science Foundation is in place, but the requisite ethical approval has not yet been received.

Margarete von Wantoch outlines the situation at the University Children’s Hospital Zurich: if predominantly well-informed people with good language skills or links to research give consent, the resulting data sets do not fully represent the entire population.

The diagnosis at various places is remarkably similar: the biggest barriers have less to do with an objection to research in principle than with timing, context and comprehensibility. Regina Grossmann says that many patients are fundamentally receptive and keen to support research; when someone says no, it is usually due to a lack of clarity – “I don’t know what I’m saying yes to” – or a sense of being overwhelmed on admission. Balgrist University Hospital and the University Children’s Hospital Zurich describe the same reasoning in their own words: the legally essential text is complex; at the same time, consent clashes with the reality of the hospital – stress, worry and a lack of time.

The suggestions have the same themes in common: earlier information, simplified decision-making and better explanation.

• Earlier information with less hassle: To Marie-Helene Suter, the best solution is to issue documents as early as possible, so that they can be read with no time pressure. Margarete von Wantoch calls for greater public education so that ideally, people know what a general consent form is and what it is used for before they actually go into hospital.
• Digitalization: Regina Grossmann describes the current level of paperwork as cumbersome and prone to error. She would like to see digital consent via patient portals, as well as more refined models such as dynamic consent where, for instance, approval is given for heart research, but not for data from psychiatric treatments.
• Opt‑out as a long-term prospect: Another potential option for the future is an opt‑out model: participation as standard, with active objection for those who are unwilling.

Thus, the general consent form becomes more than just a form. It is an attempt to enable data-driven medical research in a legally sound and ethically legitimate way while highlighting the difficulty of making abstract decisions about public welfare during acute treatment.