Article
The ethical oversight of health care improvement activities in Switzerland: a qualitative study
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Authors
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Stuart McLennan
- Universtität Basel, Institute for Biomedical Ethics, Basel, Schweiz
| Published: | March 20, 2019 |
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Outline
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Background/research question: The Swiss health care system is increasingly looking to derive knowledge from clinical practice and use this knowledge to drive the cycle of continuous health care improvement. However, blurring of the sharp distinction made by ethical oversight systems between clinical research and clinical practice can lead to uncertainty about how health care improvement activities should be ethically handled. It is important to ensure not only that participants of health care improvement activities are adequately protected and respected, but that the ethical oversight system itself does not unnecessarily undermine efforts to improve patient care. This study aims to identify the key issues regarding the ethical oversight of health care improvement activities in Switzerland.
Methods: Purposive sample of 38 key stakeholders from four different groups: health care improvement investigators (n=19), representatives of clinical trial units (n=3), clinical ethicists (n=5), quality heads of university hospitals (n=5), and cantonal ethics committee members (n=6). Data were collected via individual qualitative interviews using a researcher-developed semi-structured interview guide between July 2017 and February 2018. Interviews were transcribed, and analysed using conventional content analysis.
Results: There is currently widespread uncertainty regarding when certain health care improvement activities require ethical review by a Cantonal Ethics Committee in Switzerland. This situation is exacerbated by legislative ambiguity and the limited guidance currently available. The lack of other oversight mechanisms for activities falling outside the scope of the Human Research Act is leading many investigators to submit projects to Cantonal Ethics Committees that they know fall outside of the Human Research Act, in an effort to avoid barriers to publication.
Conclusions: This study has identified a number important areas in which the current ethical oversight health care improvement activities in Switzerland needs to be better optimized.
Competing interests: None to declare.
