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BASEC – Submission of Research Projects to Swiss Ethics Committees
Welcome to the newly redesigned and upgraded BASEC User Interface. This contains new features in the section “My account / manage my applications” that permit the users with multiple applications to sort, organize and display them as one prefers. A search function is equally available.
A short guide on what is new is accessible here.
Please note that we are still updating some form screens / parts of the application during the next few days, and therefore you might encounter some visual glitches.
We are aware of some persisting display problems with Browsers other than Google Chrome. We're working together with the software manufacturer to resolve these problems as soon as possible.
It's also recommended to clear your browser cache before working with your current or new projects.
Read before you start:
- This site is intended to optimize the submission process by guiding you in the description of your project throughout several preformatted screens.
- A short guide how to use BASEC is available here. Additionally, each screen of the submission forms contains specific instructions.
- Your project is saved automatically and you may return to and work on it again before submitting; Draft projects that were never submitted will be deleted after 6 months of inactivity.
- Backup and archive your projects on your own IT infrastructure. BASEC is not designed and not intended to be an electronic filing system (archive) for your projects.
- Reread your project carefully before submitting it. Keep in mind that once your project is submitted, the evaluation begins.
- Once you have submitted a new project you will receive an email with a unique BASEC ID number for your project. This will confirm you that your project has been received by the ethics committee and the evaluation has started. You will receive a second email within 7 days of submission, once the formal check is completed.
- For quality assurance purposes, all ethics committees in Switzerland can view and consult the submitted project in BASEC. Should you oppose to that, please contact swissethics at [email protected] before you submit the project.
- If you need to send an urgent update and your project is currently locked, please contact the ethics committee by email, phone or through the support form in the web-portal. (see also this FAQ-entry).
Clinical trials / Medical device trials: there is a new mandatory question to be answered on screen 2: "Decentralized Clinical Trials (DCT)". See form(s) for more information and links.
Clinical trials with in-vitro diagnostic products: changes in the legal requirements and BASEC
The legal requirements for clinical trials with in-vitro diagnostic products (IVDs) in Switzerland are changing. Swiss legislation is adapting to the new EU regulation on IVDs (In Vitro Diagnostics Regulation, EU-IVDR), namely, clinical research with IVDs in Switzerland will be regulated in the Ordinance on clinical trials with medical devices (ClinO-MD) starting May 26, 2022.
Consequently, submission to the ethics committee of new clinical trials with in-vitro diagnostic products after May 26, 2022, must be done through the form «Research Project Application Form for Medical Devices and In-Vitro Diagnostic Products», ONLY.
Research projects involving human embryonic stem cells (projects of human embryonic stem cells from surplus embryos) are regulated in Switzerland by the Stem Cell Research Act (StRA). As of today, all new research projects involving human embryonic stem cells must be submitted to the Ethics Committee using the submission form “RESEARCH PROJECT IN ACCORDANCE WITH THE STEM CELLS RESEARCH ACT (StRA)”.
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