Your Easy Guide to Clinical Studies

The rights, safety, and well-being of study participants must be guaranteed and remain a primary concern during study conduct(e.g. principles of ethics)

 

During study conduct::

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

 

During study recruitment, potential participants have rights and are protected by the law (Swiss law). As a consequence, consent procedures must:

• Comply with regulatory requirements (e.g. the right to ask questions and be adequately informed about study risks and procedures, the right to freely consent without the use of coercion)
• Adapt when recruiting vulnerable study participants (e.g. emergency situations, children, adolescents, adult lacking capacity, pregnant women)

As a SP-INV and Site-INV:

 

During study conduct you:

• Are responsible for participant safety and right
• Must comply with the Ethics Committee (EC) and Swissmedic (i.e. risk-category B & C studies) approved study protocol, defining participant management (e.g. study eligibility criteria, screening procedures, study intervention and study design, safety reporting procedures interim analysis for safety evaluation)

 

During participant recruitment:

• Fairly select from the target-population in a non-biased way 
• Provide participants with a written Participant Information Sheet (PIS), and orally explain the study in a way easy for participants to understand (e.g. avoid technical language).
• Inform participants of their study role and duties
• Ensure participants know their right to withdraw from the study at any time, without fearing consequences to their medical treatment
• Provide participants with adequate time to decide on study participation
• Date and sign the Informed Consent Form (ICF) together with the participant. Ensure consent is given freely

References

ICH E8(R1) – see in particular guidelines

• 2. General Principles

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

• 4 GCP summary
• 5.8 Informed consent

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

ClinO – see in particular articles

• Art. 7 Information
• Art. 7a Information in cases of genetic testing
• Art. 8 Exceptions to written form
• Art. 9 Consequences of revocation of consent
• Art. 15-17 Clinical Trials in Emergency Situations

ClinO-MD – see in particular article

• Art. 3 Applicable provisions (b,d)

HRO – see in particular articles 

• Art. 8 Information
• Art. 8a Information in cases of genetic testing
• Art. 8b Information in cases of prenatal risk assessment
• Art. 10 Consequences of revocation of consent