Submission of an ‘Advice on ethical questions/comments on research projects not subject to the HRA’
When can I ask for a comment on research projects not subject to the HRA? For which ethical questions can I ask the EC for an advice?"
The form addresses the duties according to Art. 51 lit 2 HRA. It can for example be used
a) to obtain an advice on a data registry1 or on a biobank2 (without a concomitant submission of a research project / collection of already existing data/material).
b) to obtain comments on a research project not subject to the Human Research Act (HRA) (e.g. human research projects conducted outside of Switzerland and Liechtenstein).
c) to ask ethical questions if they are closely related to medical research.
d) to obtain an advice on documents, like informed consent forms for participants to research projects.
Definitions:
1 A data registry is an organized collection of health data related to patients with a specific diagnosis, condition, or procedure.
2 A biobank is an organized repository of biological samples with their associated health data related to patients, for research.
Notes:
The submission of a data registry, a biobank or of a project not subject to the Human Research Act to the ethics committee (EC) is voluntary. As such, the submission of data registries/biobanks is done independently from the submission of the research projects, that make use of the data from the registries or material from the biobanks.
The EC will be able to review research projects involving further use of health data from registries, or with biological materials from biobanks, smoothly, if those had been previously submitted for an ethical advice.
Do not use this form if you need to know IF your project must be submitted to the EC for approval. To find out if your project falls within the scope of the HRA, use the form for Clarifications of responsibility instead (de: "Zuständigkeitsabklärung", fr: "Clarification des compétences", it: "Esame della competenza"). The FAQ for the submission of a Clarification of responsibility can be found here.
Which EC should I address?
The submission of a data registry must be directed to the EC responsible for the Canton where the person or institution with the overall responsibility for the registry (the main location) in Switzerland is located.
The submission of a biobank must be directed to the EC responsible for the Canton where the biobank in Switzerland is physically located.
If you want to submit multiple data registries/multiple biobanks, submit one form per registry/biobank.
If there are more than one site involved (multicentric), one submission to the EC responsible at the main site will suffice.
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 Advice on ethical questions/comments on research projects not subject to the HRA and click on ‘submit an application’.
How do I fill in the form?
In the form on screen 1 This submission is a request for:* select the appropriate item. The following questions and screens automatically adapt to the selected item.
Continue filling in the form following the instructions given on the form.
On the bottom of screen 4, click on Submit to submit your request to the selected EC.
A confirmation screen follows the successful submission and an automatic confirmation email will be sent to the login email address acknowledging the reception of your request.
Each data registry/biobank will be identifiable through a unique BASEC ID number (AO_YEAR-xxxxx).
The ECs will charge a fee for the ethical advice as per the scale of fees.
Research project with data/material from a submitted registry/biobank
The applicant of a research project involving further use of health data from registries, or with biological materials from biobanks, shall submit the research project to the responsible (Lead-) EC in accordance with Art. 47 HRA, that is, independently of the (voluntary) submission for an ethical advice on the registry/biobank. The applicant shall enter the BASEC ID number of the ethical advice, if available, in the Research Project Application Form to link the ethical advice to the research project.