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
    • Are asked to freely give their consent
    • Have the right to withdraw from the study at any time, without personal consequences

During study conduct:

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

What do I need to do?

As a SP-INV and Site-INV:

  • Comply with the EC/RA 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

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 14971SAMS 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

FEDLEX – laws are available online under numbers

  • 810.308 HRA
  • 810.305 ClinO
  • 810.306 ClinO-MD

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)
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Devices
  • CTU – Clinical Trials Unit
  • EC/RA – Ethics Committee / Regulatory Authorities
  • FEDLEX – Publication Platform for Federal Laws
  • 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
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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