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Submission of a clarification of responsibility (formerly : 'jurisdictional enquiry')

Solution

When should I submit a clarification of responsibility?

A clarification of responsiblity1 (formerly: jurisdictional inquiry) is submitted to the ethics committee (EC) to clarify whether the research project falls within the scope of the human research act (HRA) and / or to request a written statement2 from the ethics committee in case the research project does not need an EC approval.

If such a clarification is needed, the clarification of responsiblity must be submitted to the EC before the research project is started.

1 The clarification of responsibility is called in German “Zuständigkeitsabklärung”, in French “Clarification des compétences”, and in Italian “Esame della competenza”.

2 In the absence of on ethical approval of the research project, a written statement from the ethics committee is often asked by medical and scientific journals before accepting an article for publication. The document is provided in the language of the EC the application is submitted to. Upon specific request, the EC provides a ‘non-official’ translation in English of the clarification of responsibility (see further below for more information).

 

Where do I find the form in BASEC?

Login into BASEC and click on Submit an application in the menu bar on top of the screen. Then go to Clarification of Responsibility / Support Request and click on ‘submit an application’.

How do I fill in the form?

In the form: Type of request*: select clarification of responsibility,

and in the drop-down menu This request should be directed to* select the EC you would like to submit the clarification of responsibility. When you select the EC, please consider that the EC will answer in the official language of its canton/region. The ECs offer the option to ask for a clarification of responsibility in English (non-official translation), in addition to the official clarification issued in the language of the EC.

Continue filling in the form following the instructions given on the form.

Upload a “brief description of the project” (it's highly recommended to use this template), and any other documents that might be relevant to the ethical review, e.g. Patient Informed Consent or questionnaires that are given to the participants.

Note: Some ECs may charge a fee for the clarification of responsibility as per the scale of fees. If the EC decides that the research projects falls within the scope of the HRA and must be submitted to the EC for approval, the EC can decide not to charge for the clarification of responsibility and only charge for the regular submission. If you need more information on that, please contact the EC you intend to submit to.

Click on Submit to submit your request to the selected EC.

A confirmation screen follows the successful submission and an automatic confirmation email is sent to the login email address acknowledging the reception of the form.

Attachments:
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