Therapeutic misunderstanding

In the case of a so-called therapeutic misconception, subjects or patients wrongly assume that their participation in a clinical trial is of direct therapeutic benefit to themselves. A therapeutic misconception is a major problem for informed consent because the reason for and the aims of a research study are wrongly equated with the reason for and the aim of medical treatment. However, medical treatment or therapy on the one hand and clinical research on the other can differ significantly.

For a definition and description of the associated ethical problems, see e.g.:

Beauchamp, T. L., & Childress, J. F. (2019) Principles of Bioethics (8th edition). Oxford University Press, 132f.

The problem of therapeutic misunderstanding also arises in the case of informed consent to the secondary use of treatment data by patients. In a willingness study, for example, almost 60% of respondents stated that they themselves would also benefit from their treatment data being passed on to medical research. However, this assumption was factually unfounded.

Schickhardt, C., Mehlis, K., Winkler, E. C., & Jungkunz, M. (2024). Zur Ethik der Forschungsnutzung von Patientendaten. Die Onkologie, 30(1), 25-30., 28 https://doi.org/10.1007/s00761-023-01433-7 

Central Ethics Committee at the German Medical Association (2023). Provision and use of treatment data for research purposes. Deutsches Ärzteblatt, 120(9), A-409 / B-349, 7. https://doi.org/10.3238/arztebl.zeko_sn_behandlungsdaten2022_en

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