Three points to consider before initiating a research protocol using health data.
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1. Does the planned project require the authorization of an ethics committee?
Determine whether your project is subject to the Federal Act on Research involving Human Beings (Human Research Act, HRA / LRH in French), and to which Ordinance.
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Authorization required for projects that use traceable data and those that actively induce an effect among participants.
For projects subject to authorization, follow the steps indicated in the Swissethics flowchart to assist with the use of the templates
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No authorization is required for projects using anonymized data |
| 2. Which ethics committee should the project be submitted to? |
- You must submit your project to the commission responsible for the canton in which the research is to be carried out. In Valais, this is the Cantonal Commission on Ethics in Human Research (CER-VD).
- Depending on the type of research project, the application must be submitted to one or several ethics committees. More information
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| 3. If the planned project is not subject to prior authorization, does this mean that it is not subject to any specific legal standards? |
- No, your project is still subject to the codes of good practice and other international research regulations, which you can find out about by attending good clinical practice training courses.
- Furthermore, many journals now require an official authorization from an ethics committee prior to the publication of research results. We suggest systematically requesting a written statement from the ethics committee that confirms the project does not need an EC approval by submitting a clarification of responsibility from the CER-VD via the BASEC portal after contacting the scientific secretariat of your steering committee for a preliminary opinion.
- We remind you that publishing the results of a study, whatever they may be, is an ethical and legal obligation.
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| You have questions or doubts about any of these points? |
- The standards applicable to research projects leave open a number of questions that only the steering committee examining your study will be able to decide on a case-by-case basis.
- Whatever your level of familiarity with the regulatory framework and procedures, we advise you to contact the Applied ethical department and the scientific secretariat before any formal procedure.
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