What is it? Why is it important?

A SP-INV is liable for any damage suffered by participants in connection with study participation.

Exemptions from liability are:

  • Damages that occur in a category A study
  • Damages expected to have an equivalent occurrence under standard of care (e.g. according to instruction of use, recognised standards, validated guidelines)
  • Diseases with an immediate risk of death, and where standards of care do not exist

Notification expiration dates:

  • Notifications to insurer can be forwarded for up to ten years after the end of the study
  • Notification of a damaging event must be within three years after becoming aware of the event
  • Some studies have separate notification rules (e.g. GMO and studies using ionising radiation)

More

Under special circumstances the SP-INV might take legal action against the Site-INV or any other health professional(s) involved in a damaging event. This is especially the case if the damage occurred based on a deviation from the study protocol.

What do I need to do?

As a SP-INV:

  • Check with your institution regarding category A studies. They may have some regular in-house insurance coverage for these types of studies
  • For category B and C studies, provide additional insurance. Check with your institution for applicable insurance providers
  • Submit the study insurance certificate to EC They will need proof of insurance prior to approving the study

Insurance must cover the entire duration of the study, including a minimum of 10 years after study termination. Ensure insurance covers all participating study sites, and takes potential delays in study planning and conduct into consideration.

Where can I get help?

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

References

SAMS Research with human subjects – see in particular chapter

  • Chapter 9 Respect of participants / liability for damage

MDR 2017 – see in particular intro-points / articles

  • Intro-point 31 Damage claims
  • Intro-point 66 Civil or criminal liability
  • Art. 10 General obligations of manufacturers
  • Art. 69 Damage compensation

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.30 HRA
  • SR 220 Swiss Code of Obligations

HRA – see in particular articles

  • Art. 19 Liability
  • Art. 20 Coverage

ClinO – see in particular articles

  • Art. 10 Exemptions from liability
  • Art. 11 Extension of limitation period for ionising radiation and GMO
  • Art. 12 Exemptions from coverage requirements
  • Art. 13 Requirements for coverage

HRO – see in particular articles

  • Art. 12 Exemption from liability
  • Art. 13 Coverage

Swiss Code of Obligations:2021 – see in particular

  • Art. 60 Right to claim damages
Abbreviations
  • ClinO – Clinical Trials Ordinance
  • ClinO-MD – Ordinance on Clinical Trials with Medical Device
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • FEDLEX – Publication Platform for Federal Laws
  • GMO – Genetically Modified Organism
  • HRA – Human Research Act
  • HRO – Human Research Ordinance
  • MDR – Medical Devices Regulation
  • SAMS – Swiss Academy of Medical Sciences
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Development ↦ Ethics and Laws ↦ Liability ↦ Insurance
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): Development ↦ Ethics and Laws ↦ Liability ↦ Insurance

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