[The presumed consent legislation - A success factor or a disruptive factor for tissue donation? A qualitative study based on multidisciplinary interviews with experts].

Introduction: Tissue transplantation can improve the quality of life of patients in a very wide range of applications. In 2021, around 900 people in Germany agreed to donate organs after death - the number of tissue donors was significantly higher. Nevertheless, there is a shortage of organs and tissues in Germany. In order to counteract this, the introduction of a presumed consent legislation has been discussed time and again. However, the debates focused on possible positive effects for organ donation, whereas potential consequences for tissue donation have so far not been considered in the political discourse or in research. Using an exploratory approach, this paper aims to contribute to closing this research gap: Multidisciplinary interviews with experts were conducted to investigate whether the presumed consent legislation is a key success factor for increasing the number of tissue donors in Germany and which other approaches might be promising.

Methods: We conducted qualitative interviews with 14 experts who worked as employees in different positions in tissue banks/networks, ophthalmologists performing corneal transplantation, medical ethicists, lawyers or scientists. These interviews were evaluated using the structuring content analysis according to Mayring. In reporting, we followed the Standards for Reporting Qualitative Research (SQRQ).

Results: The majority of experts did not consider presumed consent legislation to be a key factor in increasing the donation rate in Germany. Instead, an improvement of processes and structures in tissue donation was cited as the most important optimization potential. Furthermore, communication measures were postulated to create transparency about the characteristics of tissue donation as distinct from organ donation. These should address not only the general population, but also the professional groups involved in the tissue donation process.

Conclusion: The present study indicates that the presumed consent legislation is not a success factor for increasing the number of tissue donors in Germany. It would be far more effective to improve structures and processes in order to identify the large number of potential tissue donors and to be able to conduct informed conversations with their relatives. Information measures for the general public and professionals, which clearly differentiate between tissue donation and organ donation, are also more promising than fruitless debates about the introduction of the presumed consent legislation.