Poster Presentation 2025 Joint Meeting of the COSA ASM and IPOS Congress

Less is more: Towards a patient-centred design of consent forms in the context of genetic testing (126217)

Paula Thomas 1 , Katharina Klein 1 2 , Sven Asmussen 3 , Nicolas Straub 3 , Stephanie Stegen 4 , Christoph Kowalski 2 , Dorothee Speiser 5 , Markus Feufel 6 , Friederike Kendel 1
  1. Department of Anesthesiology and Intensive Care Medicine, Charité - Universitätsmedizin Berlin, Berlin, Berlin, Germany
  2. Deutsche Krebsgesellschaft e.V., Berlin, Germany
  3. Faculty of Law, Chair of Civil Law, Commercial Law and Economics, Humboldt-Universität zu Berlin, Berlin, Germany
  4. BRCA-Netzwerk e.V., Bonn, Germany
  5. Hereditary Breast and Ovarian Cancer Center, Department of Gynecology, Charité - Universitätsmedizin Berlin, Berlin, Germany
  6. Department of Psychology and Ergonomics (IPA), Division of Ergonomics, Technische Universität Berlin, Berlin, Germany

Objective:

Informed consent is the ethical and legal pillar of patient autonomy. However, in practice, the consent process is often non-transparent and possibly overwhelming for patients. In an effort to meet legal requirements, consent forms tend to cover all information that could potentially be relevant, resulting in documents that are extensive and difficult to understand. Genetic testing for hereditary breast and ovarian cancer risk can be regarded paradigmatic for this issue since it involves consenting to a large number of data processing aspects besides consent to the testing procedure itself. We therefore aimed to explore the importance of various consent aspects from the perspective of patients.

Methods:

As part of the interdisciplinary project dVP_FAM (funded by the German Federal Joint Committees, 01NVF20002), a cross-sectional online study with N = 224 individuals with a family history of cancer was conducted. We assessed the subjective importance of 14 items typically covered in consent forms for genetic testing (analyzed using multiple contrast tests) extended by open-text responses (analyzed using qualitative content analysis).

Results:

While the majority of consent aspects were rated important in absolute terms, we observed relative differences. Specifically, consent aspects reflecting a direct benefit for the patient and their family were rated as more important. In addition, two major themes were identified in the qualitative analysis: “protection and secure handling of genetic data” and “ethical considerations”.

Discussion and practical implications:

Our results show that patients express less concern about the “technical” aspects of data processing, but rather prioritize personal and ethical facets of the collection of genetic data. Our results will support the development of alternative consent forms that align with patient-relevant content while ensuring full compliance with statutory legal requirements. Simplifying and tailoring consent forms to patients’ concerns may promote satisfaction and support decision-making in genetic testing and beyond.