Research projects falling under the Human Research Act

The University support researchers with projects involving human participants.

Service includes:

  • Guidance on legal aspects of research projects and ethics committee submissions
  • Drafting and review of research contracts, including collaborations with other institutions and transfer of health-related personal data or biological material
  • Advice on the protection of health-related personal data
  • Assistance with insurance guarantee requests

To determine whether your project falls under the HRA, please see here:

Human Research Overview

Learn more about the HRA process and requirements

  • Liability insurance

    Research projects and clinical trials subject to the HRA must be covered by a specific insurance for any harm that may be caused to participants. However, some projects and trials are excluded from this liability insurance requirement, depending on the risk category:

    • Category A clinical trials and clinical trials on medical devices involving measures for sampling of biological material or collection of health-related personal data which entail only minimal risks and burdens;
    • Category A research projects.

    Please contact us to initiate the insurance guarantee request. 

  • Submitting an of application to the Swiss ethics committees

    If a research project falls within the scope of the HRA, an authorization from the responsible ethics committee is required. 

    The canton of Fribourg does not have an ethics committee. The ethics committees of the cantons of Bern and Vaud are responsible for projects carried out in the canton of Fribourg.

    All applications for authorization must be submitted via the  BASEC platform.

  • Templates for applications

    Swissethics provides useful study protocol templates, forms and user guides to assist researchers in submitting applications for authorization to the Swiss ethics committees. The templates cover all aspects required by the Swiss federal legislation. We therefore recommend that you follow these templates in order to fully comply with the relevant requirements. They also facilitate and speed up the assessment by the ethics committee. The templates are regularly updated by Swissethics. All new applications must be based on the latest online versions.

    The DIT-ER has developed text templates for the ‘Quality Control and Data Protection’ section of study protocols when the platform REDCap@UniFR is used for the management of personal health-related data. We recommend their use.

    When submitting to an ethics commission a research project involving artificial intelligence (AI), fundamental AI-specific issues must be addressed. Swissethics provides  guidelines containing a series of key questions. 

    Sex and gender differences in research design, study implementation and scientific reporting must be taken into account.
    Recommendations from Swissethics for better consideration of sex and gender in human research, that include a checklist designed to guide researchers in the writing of their study protocols and other related documents.

  • Research agreements

    If multiple institutions are involved in the same research project or clinical trial, research agreements are required. These must be submitted to the ethics committee for approval. Transfer agreements must also be concluded for the transfer and reuse of health-related personal data or biological material in a new research project.

    Process

    • Please contact us as soon as possible so that we can provide you with the most appropriate agreement template.
    • You then complete and adapt the template to your research project or data/material transfer, and submit it to us for review.
    • You send the revised draft agreement to the partner institution.

    When the partner institution submits a fully drafted agreement to you, we will review it from a legal perspective.

    Research contracts must be signed by the Rector. Legal validation of the agreement is required before it can be submitted to the Rector.

    . Depending on the complexity of the contract, it may take several weeks to draft the contract and hold discussions with all parties in order to obtain a version that has been approved by each partner.

  • Further information

    The  Swiss Clinical Trial Organisation (SCTO) and its network of Clinical Trial Units (CTU) develop tools and guidance in a number of key areas of research involving human beings. Their  platforms provide advice, online seminars and practical tools for researchers to help them carry out their research projects and clinical trials.

    Swissethics strongly recommends that all persons involved in research projects subject to the HRA undergo or renew training in Good Clinical Practice (GCP). This training is mandatory for investigators in clinical trials subject to the OClin.List of recognized research ethics and GCP course providers in Switzerland

    De-identification of health-related personal data: The Swiss Personalised Health Network (SPHN) has developed a legally compliant methodology and a practical Risk Assessment tool that allows to identify re-identification risks; the guide allows to select appropriate de-identification rules for the data and define contextual risk mitigation measures. The resources are available  here. The use of this tool is not mandatory but is recommended by Swissethics to demonstrate that the data to be transferred is sufficiently de-identified.

    The CPCR Service Finder is a collaborative tool developed by the national Coordination Platform Clinical Research with other Swiss health research organisations . It is designed for anyone involved in health and clinical research in Switzerland, from academic researchers and study coordinators to data managers and biobank professionals. The tool supports users in identifying which national infrastructures can provide the expertise, data, or resources they need at different stages of their projects.

Contact

For legal, contractual and insurance questions or support for research projects involving human subjects, please contact Julie Perriard (legal officer)