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Ethical challenges in biomarker research and precision medicine - a qualitative study in dermatology
Marie-Christine Fritzsche1,2, Nora Hangel3, Alena Michaela Buyx4,5
1Institute of History and Ethics in Medicine, TUM School of Medicine and Health, Technical University of Munich, Ismaninger Straße 22, 81675, Munich, Germany. marie-christine.fritzsche@tum.de.
Background:
Over 300 million individuals worldwide live with Atopic Dermatitis and Psoriasis, which are among the most common chronic inflammatory skin diseases. Multimodal biomarkers are currently being developed using large-scale data and artificial intelligence to allow for more targeted prediction and to improve treatment of patients with Atopic Dermatitis/Psoriasis. Although this promises enormous benefits for patients, it comes with critical challenges. This article offers an in-depth analysis of the ethical challenges in research and application of data-driven biomarkers in chronic inflammatory skin disease, which, as recent work shows, has not yet been explored in depth.
Methods:
We conducted an interview study with 28 members of the BIOMarkers in Atopic Dermatitis and Psoriasis consortium including multiple stakeholder groups involved in biomarker research and application following the COREQ checklist. The interviews were analysed and interpreted theme-oriented using an updated grounded theory approach.
Results:
The interviews revealed interconnected ethical challenges described by a wide range of stakeholders involved in biomarker research. Our analysis identified two broad categories of ethical challenges - disease-related and biomarker-related issues - from which three cross-cutting themes emerged: multiple forms of harm, multiple injustices, and multiple uncertainties. Disease-related challenges include covert psycho-socio-physical dimensions of harm and suffering in Atopic Dermatitis/Psoriasis, quality of life impacts, trial-and-error approaches, and communication and expectation management in clinical practice. Biomarker-related challenges range from big data use with multiple biases in the different data-sets, stratification of patients into subgroups, to invasiveness of diagnostic measures, multiple uncertainties and expectation management in science. This article also provides stakeholder suggestions for mitigating harm associated with Atopic Dermatitis/Psoriasis and biomarker use to inform policy development.
Conclusions:
The identification of the many ethical challenges uncovered in the interviews and the nuanced view of harm, intersecting injustices including epistemic injustice, and the multiple uncertainties provide crucial considerations for evaluating the risks and benefits of biomarker research and application in healthcare. These insights should inform policy development for data/AI-driven biomarker use for Atopic Dermatitis/Psoriasis and support research practice, public health interventions, and clinical practice to develop and apply medical innovations that are ethically responsible.
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