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

Details

Serval ID
serval:BIB_5CA767B6327A
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Uncertainties about the need for ethics approval in Switzerland: a mixed-methods study
Journal
Swiss Medical Weekly
Author(s)
Gloy Viktoria, McLennan Stuart, Rinderknecht Matthias, Ley Bettina, Meier Brigitte, Driessen Susanne, Gervasoni Pietro, Hirschel Bernard, Benkert Pascal, Gilles Ingrid, von Elm Erik, Briel Matthias
ISSN
1424-3997
ISSN-L
0036-7672
Publication state
Published
Issued date
12/08/2020
Peer-reviewed
Oui
Volume
150
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Abstract
To ensure ethical oversight, researchers wanting to conduct “research” involving human beings are typically required to obtain prior approval from an independent ethics committee. However, it can sometimes be unclear if a project needs to be submitted for ethics approval. Swiss researchers can contact research ethics committees via a “jurisdictional inquiry” for clarification whether a project needs to be submitted for ethics approval.
(1) To examine the characteristics of Swiss jurisdictional inquiries, and (2) to identify possible uncertainties regarding the correct interpretation of existing legislation in Switzerland.
All jurisdictional inquiries submitted to Swiss research ethics committees between July and December 2017 were reviewed using qualitative content analysis. We then conducted an online survey between June 2018 and July 2018 with all researchers who had submitted a jurisdictional inquiry including a descriptive quantitative analysis.
The review included 271 jurisdictional inquiries. Analysis identified three groups of jurisdictional inquiries: 80.4% (218/271) sought clarification whether the project had to be submitted for ethical approval; 18.5% (50/271) requested a “declaration of no objection”; and 1.1% (3/271) asked for a clarification about which of the two ordinances was applicable to the project. Analysis identified eight distinct legal issues that appeared to be the main cause for a number of jurisdictional inquiries, with the two most frequently identified issues being whether the project will produce generalisable knowledge, and whether the project uses fully anonymised data. Overall, research ethics committees decided that 78.6% (213/271) of the jurisdictional inquiries were outside their jurisdiction and did not require ethical approval, and that 15.6% required submission for ethical approval. The online survey achieved a 56.8% response rate. The majority of respondents (94/166; 56.6%) reported that all the questions they were asked during the submission of the jurisdictional inquiry were easy to understand. Respondents reported that 88% (147/166) of all projects were started or planned to start. The vast majority (154/166; 93%) of respondents also agreed with the decisions made by the research ethics committee.
Jurisdictional inquiries are an important means for researchers to clarify whether their project requires ethical oversight. However, this mixed-methods study has identified some difficulties in the interpretation of legal terms, which often reflect persistent structural issues that many other countries also face. More detailed guidance may be helpful to reduce the researchers’ uncertainties and ethics committees’ workloads in relation to jurisdictional inquiries.
Keywords
General Medicine
Pubmed
Web of science
Open Access
Yes
Create date
07/09/2020 15:45
Last modification date
13/11/2020 6:26
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