Research involving human beings (research HRA)

We support you in your human research projects by providing the following services:

• Assistance with all legal issues related to your research project and the submission of the application to the ethics committee
• Contractual support: drafting and reviewing research contracts for collaboration with other institutions, and for the transfer of health-related personal data or biological material
• Support regarding the protection of health-related personal data
• Point of contact for insurance guarantee requests

Legislation and guidelines for research involving humans

• Application of the HRA

  The Human Research Act (HRA) applies to research projects and clinical trials that present a potential threat to the dignity, privacy and health of human being involved in research. These are projects that meet the following criteria:

  • research in the field of health:
    • research on diseases (research on the causes, prevention, diagnosis, treatment and epidemiology of impairments of physical and mental health in human beings) or
    • research on the structure and function of the human body (basic research, in particular on human anatomy, physiology and genetics, and non-disease-related research concerning interventions and impacts on the human body)
  • and research involving:
    • persons (or deceased persons or embryons/foetuses), or
    • biological material, or
    • health-related personal data

  If you have any doubts about whether the research project falls within the scope of the HRA, you may submit a clarification of responsibility to the Swiss ethics committees.
  You may also contact us.

• Liability insurance

  The risk categories and the liability insurance requirements vary depending on whether the research project is subject to the Human Research Ordinance (HRO), the Clinical Trials Ordinance (ClinO) or the Ordinance on Clinical Trials with Medical Devices (ClinO-MD).

  In principle, research projects subject to the HRA must be covered by a specific insurance for any harm that may be caused to participants. 
  Please contact us to initiate the insurance guarantee request. 

  However, the following projects are excluded from the liability insurance requirement: 

  • 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.
• 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.

  • For projects in a German-speaking context (language of the project, the researcher, or the project participants), the Ethics Committee of the Canton of Bern (KEK Bern) is responsible.
  • For projects in a French-speaking context (language of the project, the researcher, or the project participants),the Ethics Committee of the Canton of Vaud (CER-VD) is responsible.

  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.

  • General guide to assist with the use of the right template for writing a protocol, a participant information and consent form
  • Study protocols by type of research
  • Patient information and declaration of consent for participants in studies
  • Recruitment of study participants
  • Research on and with children and adolescents
  • Notification of protocols amendments

  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.

  • Research projects according to HRO
  • Clinical trials according to ClinO
  • Other clinical trials according to chapter 4 of ClinO
• 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 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

  The study protocol for any research project involving AI must address the key AI-specific issues

  Guide from Swissethics containing a set 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.

  De-identification of health-related personal data: The Swiss Personalised Health Network (SPHN) has developed a legally compliant methodology and a practical tool for its implementation. The Risk Assessment Tool allows project leaders 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.