Research involving human subjects (research HRA)

The Legal Department supports you in your human research projects by providing the following services:

• Contractual support: provision of templates for research contracts (collaboration agreement, data transfer agreement, etc.) and review of your draft contracts
• Assistance with all legal issues related to the submission of applications to the Swiss ethics committees
• Provision of information and links specific to human research

Legislation and guidelines for research involving humans

• Categorization and Risk Coverage

  Application of the HRA

  The Human Research Act (HRA) applies to research projects 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 the biological material and health-related personal data are anonymized, the HRA does not apply.

  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.

  Categories and risks

  KOFAM’s Categoriser tool can be used to determine the classification and risk category of your research project, with examples and explanations linked to Swissethics’ models and insurance documents.

  In principle, research projects subject to the HRA must be covered by insurance for any harm that may be caused to participants. Certain risk categories are exempted from the liability coverage requirements.

  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).

  For more details on risk categories and insurance cover

   

  Presentation by the Coordination Office for Human Research of the FOPH, kofam.ch
• 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.

  For German-speaking research projects in Fribourg, the Ethics Committee of the Canton of Bern (KEK Bern) is responsible.

  For French-speaking research projects in Fribourg, the Ethics Committee of the Canton of Vaud (CER-VD) is responsible.

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

  If multiple institutions are involved in the same research project, it may be necessary to conclude a research agreement (data transfer agreement, collaboration agreement, etc.). The Legal Department will assist you in drafting the required agreement.

• Templates

  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 Swiss ethics committees. 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
  • General insurance conditions and insurance certificate templates for projects requiring liability insurance (depending on the risk category)
  • Recruitment of study participants
  • Research on and with children and adolescents
  • Notification of protocols amendments

   

• 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 clinical research. Their platforms provide practical solutions for researchers involved in academic research, for example:

  • The interactive Easy Guide to Clinical Studies provides relevant information and practical guidance on how to plan and conduct a clinical study in a compliant matter.
  • The Risk Assessment Form helps you identify potential quality risks in your clinical research project, assess these risks and develop strategies to overcome them. It complies with GCP requirements.
  • The Regulatory Affairs Platform regularly publishes an online journal and keeps track of legislative revisions, new standards and guidelines for clinical research in Switzerland.

  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 Ethics Committee of the Canton of Vaud (CER-VD) organizes regular virtual meetings (LRH lunches) to discuss HRA issues. These meetings are open to anyone interested in the subject. The CER-VD also publishes recommendations on specific topics such as bachelor/master theses or artificial intelligence, algorithms, and machine learning.