The value of consent

Health data is the raw material of precision medicine – researchers are only allowed to use it with the patients' consent. The University Hospital Zurich, Balgrist University Hospital and the University Children's Hospital Zurich obtain and handle this consent in different ways. However, the challenges involved are similar.

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.

Fuel for research

Medical data and biological samples have long been more than a by-product of healthcare. They enable a better understanding of diseases, the comparison of therapies, and more targeted improvement of healthcare. 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.

Three institutions, one principle – different practice

"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 per cent, and sometimes even higher," Grossmann adds.

As consent documents can quickly become time-consuming for hospital staff, the University Hospital Zurich also wants them to be comprehensible: in a "patient and public involvement" approach, in collaboration with patient representatives, videos and infographics have been developed to show clearly 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 an information website. The University Hospital Zurich makes the form available in 15 languages.

Legally precise – and therefore lengthy

At Balgrist University Hospital, out-patients and in-patients 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.

The exact return rate at the Balgrist is not known, as the percentage of signed forms is not systematically assessed. Marie-Helene Suter estimates that at least 50 per cent of patients agree to give their consent. She 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. This makes it inaccessible for some – yet legal precision is essential.

Concern among parents

At the University Children’s Hospital Zurich, the situation is changing again. Margarete von Wantoch, head of the Clinical Trial Unit, explains that young people aged 14 or over who are capable of judgement 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 on the first visit; the form has two pages and explains details such as the purpose, the encryption and confidentiality of data, the voluntary nature of consent, and the ability to withdraw it.

The return rate is around 70 per cent, says von Wantoch. She points out that many forms are returned without a yes or a no. There are no resources for systematic follow-up, and the issue comes 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 that has nothing to do with healthcare.

When consent forms a pattern: Bias as a research problem

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: when generally well-informed people with good language skills or links to research give consent, this results in data sets that do not fully represent the entire population.

A problem with the process, not an aversion to research

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.

What can be improved – from digitalisation to opt‑out

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.
• Digitalisation: 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.

So the general consent form is more than a form. It is an attempt to allow research in data-driven medicine in a legally sound and ethically legitimate way, while also highlighting how hard it is to grapple with abstract decisions on public welfare in acute times of treatment.

General consent is voluntary permission from patients to allow encrypted health data and leftover diagnostic samples such as blood and tissue samples to be used subsequently for research purposes. This consent can be withdrawn, and has no influence on treatment.

Text: Marita Fuchs

Photo: Frank Brüderli