Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Switzerland.
Department of Clinical Research, Basel Institute for Clinical Epidemiology and Biostatistics, University of Basel and University Hospital Basel, Switzerland / Institute for Biomedical Ethics, University of Basel, Switzerland / Institute of History and Ethics in Medicine, Technical University of Munich, Germany.
Swiss Med Wkly. 2020 Aug 12;150:w20318. doi: 10.4414/smw.2020.20318. eCollection 2020 Aug 10.
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.
为了确保伦理监督，希望进行“研究”的研究人员通常需要获得独立伦理委员会的事先批准。然而，有时尚不清楚项目是否需要提交伦理批准。瑞士研究人员可以通过“管辖权查询”联系研究伦理委员会，以澄清项目是否需要提交伦理批准。
（1）检查瑞士管辖权查询的特征，（2）确定瑞士现有立法的正确解释方面可能存在的不确定性。
对 2017 年 7 月至 12 月期间提交给瑞士研究伦理委员会的所有管辖权查询进行了审查，并使用定性内容分析进行了审查。然后，我们于 2018 年 6 月至 7 月期间对所有提交管辖权查询的研究人员进行了在线调查，包括描述性定量分析。
审查包括 271 项管辖权查询。分析确定了三组管辖权查询：80.4%（218/271）寻求澄清项目是否必须提交伦理批准；18.5%（50/271）要求“不反对声明”；1.1%（3/271）要求澄清适用该项目的两项条例中的哪一项。分析确定了八个不同的法律问题，这些问题似乎是许多管辖权查询的主要原因，其中两个最常被确定的问题是项目是否会产生可推广的知识，以及项目是否使用完全匿名数据。总体而言，研究伦理委员会决定，78.6%（213/271）的管辖权查询超出了其管辖范围，无需伦理批准，而 15.6%需要提交伦理批准。在线调查的回应率为 56.8%。大多数受访者（94/166；56.6%）表示，他们在提交管辖权查询时提出的所有问题都很容易理解。受访者报告说，88%（147/166）的项目已经开始或计划开始。绝大多数（154/166；93%）的受访者也同意研究伦理委员会的决定。
管辖权查询是研究人员澄清其项目是否需要伦理监督的重要手段。然而，这项混合方法研究发现，在解释法律术语方面存在一些困难，这通常反映了许多其他国家也面临的持续结构性问题。更详细的指导可能有助于减少研究人员的不确定性和伦理委员会在管辖权查询方面的工作量。
