How to Apply for an Ethics Approval for your MR-research

🇨🇭 How to Apply for an Ethics Approval for Your MR-Research

Navigating the ethics approval process for your MR research can be a daunting task, particularly when investigator-initiated trials (IIT) and strict legal compliance are involved. Even after securing funding from organizations like the Swiss National Science Foundation (SNSF) or the EU Commission, the real regulatory challenge begins. A significant amount of legal and procedural work awaits, and careful planning is essential to streamline the process.

🇨🇭 Submit Ethics and Swissmedic Applications in Parallel

For IITs involving non-CE-marked medical devices or investigational methods in Switzerland, you must submit your application to both Swissmedic and your Cantonal Ethics Committee (CEC) on the same date. This ensures that your trial meets the requirements of ClinO-MD (Ordinance on Clinical Trials with Medical Devices).

Why Parallel Submissions? Swissmedic focuses on the safety and compliance of the investigational device, while the ethics committee assesses the scientific, ethical, and participant safety aspects of your study. Any delays in one submission can hold up the other, so working on both applications simultaneously is critical.

Submission Platforms

  • Swissmedic: Applications for investigational devices are submitted through the eGov Portal: Swissmedic eGov Platform
  • Ethics Committees: Ethics applications are submitted via BASEC (Business Administration System for Ethics Committees): BASEC Ethics Portal

🇨🇭 Choosing the Right Cantonal Ethics Committee

In Switzerland, you must submit your ethics application to the CEC of the canton responsible for your research. This is typically:

  • The canton where you live
  • The canton where your research is conducted, if different.

If the canton where you conduct your research lacks its own ethics committee, submit your application to the CEC designated for that region. For me, as a researcher based in Bern, this was the Cantonal Ethics Committee Bern (KEK-Bern). The website of the KEK-Bern has, unfortunately, only a German and a French version and is therefore for international researchers not really optimal. Even worse, the human research related website of CEC-Zürich, CEC Northwest- and Central Switzerland (EKNZ) as well as that of eastern Switzerland Switzerland (EKOS)  which is only available in German and website of canton Ticino, CEC-Ticino, is only available in Italian. The CEC of Geneva and CEC-Vaud appear  more internationally accessible, as their websites are available in English.

🇨🇭 Important Considerations for BASEC Submissions

When submitting your ethics application via BASEC, keep the following in mind:

  1. Prepare a Comprehensive Application:
    • Include all study protocols, informed consent forms, and safety documentation.
    • Ensure clarity in your study’s purpose and methodology.
  2. Device-Specific Documents:
    • For investigational MR pulse sequences or RF coils, submit detailed technical descriptions and risk assessments (e.g., SAR calculations, peripheral nerve stimulation risks). You must upload the IB, but your local CEC will not review it, since this is done by Swissmedic.
  3. Investigator Brochure (IB):
    • Ensure your Investigator’s Brochure (IB) is accurate and includes all relevant preclinical and clinical data for the investigational device or method. You must upload the IB, but your local CEC will not review it, since this is done by Swissmedic.
  4. Clinical Investigation Plan (CIP):
    • Your CIP must clearly outline the study objectives, methodology, and participant safety measures.
  5. Deadlines and Review Timelines:
    • Be aware of submission deadlines and estimated review timelines for both BASEC and Swissmedic. Coordination is crucial to avoid unnecessary delays.
  6. Emergency Planning:
    • Include detailed contingency plans for participant safety, particularly for investigational hardware or methods.

🇨🇭 Streamlining Your Workflow

Given the complexity of the process, here are some tips to stay organized:

  • Work in Parallel: Develop your Swissmedic and BASEC applications simultaneously to meet the same-date submission requirement.
  • Use Templates and Resources: Both Swissmedic and BASEC provide helpful templates and guidance documents. Leverage these to ensure your application meets all formal requirements.
  • Stay Updated and Use provided Application Forms and Templates Effectively
    • Always Use the Latest Versions: It’s essential to ensure compliance with current regulatory standards by using the most up-to-date versions of templates provided by Swissmedic.
    • Check for Updates Regularly: Swissmedic frequently revises templates and guidance documents, so make it a habit to check their official website for the latest versions.
    • Streamline Your Submission: By utilizing these templates, you can facilitate a more efficient and accurate submission process, presenting all necessary information clearly and in line with Basec and Swissmedic requirements.
  • Try to Stay in Communication: Proactively engage with your local CEC and Swissmedic during the preparation process to clarify any questions about documentation or procedures.

🇨🇭 From Theory to Practice

Enough with the dry theory! Let’s dive into the practical side. In the following posts, I’ll guide you through concrete steps and provide valuable insights to help you effectively craft your ethics proposal. Whether you’re tackling challenging requirements or aiming for clarity, these posts are designed to make the process smoother and more manageable.

The following material about writing an MR-clinical trial related ethics application available in this blog:

🇨🇭 Acknowledgements: registries and governmental organs

This entire blog is based on my SNSF approved project entitled:

  • Title: Non-invasive Monitoring of Brain Metabolites Using Novel and Adapted Proton and
    Deuterium MRS Techniques
  • BASEC Acronym: SIGNATURES2023

The study is registered at the following governmental organizations: 

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