What is it? Why is it important?

In studies, the rights, safety, and well-being of study participants must be a primary concern and guaranteed at all times.


At participant recruitment:

  • Selection is fair and not based on vulnerability, privilege or other factors resulting in a biased selection
  • Participants:
    • Are informed about potential study risks (e.g. orally and in writing PIS))
    • Are asked to freely give their consent (e.g. sign an Informed Consent Form (ICF))
    • Have the right to study information, including information on data concerning them
    • Have the right to withdraw from the study at any time, without consequences


During study conduct:

  • Study related tasks are only implemented after participants have given their consent (e.g. however special procedures apply for studies in emergency situations)
  • Participant safety always takes precedence over research interests. The risk-benefit ratio of the study must remain favourable
  • Participant privacy and confidentiality are protected at all times (e.g. data coding and anonymisation)

What do I need to do?

As a SP-INV and Site-INV:

  • Comply with the Ethics Committee (EC) / RA (e.g. Swissmedic) approved study protocol (e.g. eligibility criteria, screening procedures, intervention and study design, safety reporting procedures)
  • Inform participants of their study role and duties, including potential risks
  • Ensure participants:
    • Are recruited fairly
    • Provide consent free from coercion
    • Know about their rights to withdraw from the study, without having to provide an explanation or be concerned about undesirable consequences


In the event of vulnerable study participants, follow consent procedures as defined in the law (e.g. emergency situations, children, adolescents, adult lacking capacity, pregnant women)


Participant recruitment procedures must be non-discriminatory. If you decide to exclude or include a disproportionate group of people (e.g. gender, age, race, genetic profiling), objective reasons must be provided to EC/RA.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic


ISO 14155:2020 Medical device (access liable to costs) – see in particular sections and annexes

  • 4 GCP summary
  • 5.8 Informed consent
  • 6.2 Risk management
  • 7.4.4 Adverse events risk assessment
  • 9.2.4 Monitoring General
  • Annex B Investigator’s brochure
  • Annex H Application of ISO 14971

SAMS manual “Research with human subjects” – see in particular chapters

  • Chapter 4 Scientific requirements
  • Chapter 5 Selection of study participants
  • Chapter 6 Assessment of risk and benefits
  • Chapter 8 Information and consent
  • Chapter 9 Respect of participants

Swiss Law

HRA – see in particular articles

  • Art. 6 Non discrimination
  • Art. 7 Consent
  • Art. 8 Right to receive information
  • Art. 12 Risks and burdens
  • Art. 16 Informed consent
  • Art. 21-24 Research involving children, adolescents and adults lacking capacity
  • Art. 30-31 Research in Emergency situations
  • Art. 15-17 Clinical Trials in Emergency Situations

ClinO – see in particular articles

  • Art. 7 Information
  • Art. 8 Exceptions to written form
  • Art. 9 Consequences of revocation of consent

ClinO-MD – see in particular article

  • Art. 3 Applicable provisions (b,d)
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • GCP – Good Clinical Practice
  • HRA – Human Research Act
  • ISO – International Organization for Standardization
  • SAMS – Swiss Academy of Medical Sciences
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Conduct ↦ Ethics and Laws ↦ Participant Protection ↦ Requirements

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Drug or Device

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Quality and Risk
Set-Up Drug or Device

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Drug or Device

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistics
Completion Drug or Device
Current Path (click to copy): Conduct ↦ Ethics and Laws ↦ Participant Protection ↦ Requirements

Please note: the Easy-GCS tool is currently under construction.