What is it? Why is it important?

Participants who agree to participate in a study or research project have rights, such as:

 

  • To be truly and completely informed about:
    • Known and expected study risks
    • Additional safety risk or concerns as soon as they become available
    • Measures taken to protect their personal data and biological material
    • Potential benefits to them or others with the same disease

 

  • Their right to:
    • Ask questions regarding study participation and conduct (e.g. nature, purpose, duration)
    • Contact study staff in the event of safety issues or other concerns
    • Withdraw from the study at any time without penalties to their ongoing medical treatment
    • Information regarding treatment results or results relating to their health
    • Have any recorded data errors corrected or deleted

What do I need to do?

As a SP-INV or Site-INV:

  • Know the rights of study participants
  • Ensure rights are documented in the Patient Information Sheet (PIS) for participants to read or refer to during study conduct
  • Ensure participants understand their rights before being asked to sign the Informed Consent Form (ICF)

 

It is the responsibility of the SP-INV and Site-INV to make sure participants know and understand their rights. In the event of:

  • Communication problems (e.g. language), plan for an independent qualified translator to be consulted
  • Physical or cognitive problems, plan for information and consent to be provided in a non-written form, with a written confirmation from a witness confirming adherence to the informed consent process

Where can I get help?

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

References

The Federal Act on Data Protection - see in particular

  • Art. 6 Principles

Declaration of Helsinki – see in particular

  • 4, 7-9, 14 General principles

ICH GCP E6(R2) – see in particular guidelines

  • 4.8 Informed Consent

Swiss Law

HRA – see in particular articles

  • Art. 8 Right to receive information
  • Art. 15 Safety and protective measures
  • Art. 16 Informed Consent

ClinO – see in particular articles

  • Art. 7 Information
  • Art. 8 Exception to written form
  • Art. 9 Consequences of revocation to consent
  • Art. 18 Storage of health-related data and biological material

HRO – see in particular article

  • Art. 5 Storage of health-related data and biological material
Abbreviations
  • CTU – Clinical Trials Unit
  • ClinO – Clinical Trials Ordinance
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation Good Clinical Practice
  • PIS – Participant Information Sheet
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Development ↦ Protocol ↦ Study Participants ↦ Participant Right
Study
Basic

Provides some background knowledge and basic definitions

Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Statistic Methodology
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Ethics and Laws
Set-Up Statistic Methodology
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Statistic Methodology
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Statistic Methodology
Completion Drug or Device
Current Path (click to copy): Development ↦ Protocol ↦ Study Participants ↦ Participant Right

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