Your Easy Guide to Clinical Studies

A SP-INV / Project Leader is liable for any damage suffered by participants in connection with study participation. In this respect, insurance provides:

• Study participants with financial compensation, should they suffer harm
• Researchers with financial protection, in the event of damages to participants

 

Exemptions from liability are:

• Damages in a risk-category A study. Institutions often have regular in-house liability coverage for these types of studies
• 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

 

 

Under special circumstances the SP-INV may take legal action against a Site-INV, or any other health professional(s) involved in a damaging event. This is especially the case if the damage occurred as a result of a protocol deviation.

 

Insurance coverage refusal may arise if SP-INV / Site-INV malpractice and/or negligence is proven.

As a SP-INV:

• Make yourself familiar with insurance responsibilities at your institution
• For risk-category B and C studies, provide additional insurance. Check with your institution for applicable insurance providers
• Inform yourself regarding procedures for the notification of damages and relevant expiration dates
• Include an insurance certificate during Ethics Committee (EC) submission, as EC will need proof of insurance prior to study / project approval

 

 

Study Insurance must cover:

• All studies / research projects. Requirements depend on expected risks to study participants (e.g. study / project risk-category)
• The entire duration of a ClinO / ClinO-MD study, including up to 20 years after study termination
• The entire duration of a HRO research project, including up to 10 years after study termination
• In a multicentre study, all participating study sites
• Potential additional time, not calculated during study / project planning, due to unforeseen delays (e.g. study amendment, participant recruitment delays)

External Links

Swissethics – see in particular

• Insurance template

References

ICH GCP E6(R3) – see in particular guidelines

• 3.14 Trial insurance
• Appendix B.15 Financing and insurance

ISO 14155:2020 Medical devices  (access liable to cost) - see in particular section

• 5.6.2. Ethics submission 

Declaration of Helsinki – see in particular principle

• 15 Subject compensation and treatment

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

HRA – see in particular articles

• Art. 19 Liability
• and 20 Coverage

ClinO – see in particular articles and annex

• Art. 10 Exemptions from liability
• Art. 11 Extension of limitation period for ionising radiation and GMO
• Art. 12 Exemptions from liability coverage requirements
• Art. 13 Requirement for liability coverage
• Art. 14 Protection of the injured party
• Annex 3 Ethics application

ClinO-MD - see in particular articles

• Art. 3c Liability and coverage

HRO – see in particular article and annex

• Art. 13 Coverage
• Annex 2 Ethics application

Swiss Code of Obligations – see in particular

• Art. 60 Right to claim damages