Your Easy Guide to Clinical Studies

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)

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.

References

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)