Uncertainties about the need for ethics approval in Switzerland: a mixed-methods study

Area of Science:

• Medical Ethics
• Research Governance
• Swiss Healthcare Policy

Background:

• Researchers require ethics committee approval for human research.
• Clarifying submission requirements via jurisdictional inquiries is crucial in Switzerland.
• Uncertainty exists regarding when projects necessitate ethics approval.

Purpose of the Study:

• Characterize Swiss jurisdictional inquiries.
• Identify legislative interpretation uncertainties for researchers.
• Improve clarity in research ethics oversight.

Main Methods:

• Qualitative content analysis of 271 jurisdictional inquiries (July-Dec 2017).
• Online survey of researchers who submitted inquiries (June-July 2018).
• Descriptive quantitative analysis of survey responses.

Main Results:

• Most inquiries (80.4%) sought clarification on ethical approval necessity.
• Key issues included data generalizability and anonymization.
• Ethics committees deemed most inquiries (78.6%) outside their jurisdiction.
• Researchers generally agreed with committee decisions.

Conclusions:

• Jurisdictional inquiries are vital for ethical oversight clarification.
• Difficulties in interpreting legal terms highlight structural issues.
• Enhanced guidance could reduce researcher uncertainty and committee workload.