What is it? Why is it important?
Liability coverage is an insurance that provides the insured party (the study SP-INV and hospital) with financial protection against claims (from study participants) resulting from injuries and damages sustained from study participation.
Liability coverage must cover claims, which are submitted for up to 10 years after the end of the study, including:
- HRO research projects: research involving measures for sampling of biological material or the collection of health-related personal data from persons
- ClinO clinical studies: studies of medicinal products, in vitro diagnostic medical devices or combinations / transplantation of human organs, tissues and cells / other clinical studies
- ClinO-MD clinical studies: studies with medical devices
Notification of a damaging event must be within three years after becoming aware of the event. Time-barred claims are further defined in the Swiss Code of Obligations.
What do I need to do?
As a SP-INV and Site-INV, be aware that the liability coverage of your study does not end with the study, but remains valid for a minimum of an additional 10 years.
Thus, in the event of study-related damage claims during this extended period, proceed as required.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
Declaration of Helsinki – see in particular principle
- 34 Post-Trial Provisions
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
FEDLEX – laws are available online under numbers
- 810.308 HRA
- 810.305 ClinO
- 810.306 ClinO-MD
- 220 Code of Obligations
- 810.301 HRO
HRA – see in particular article
- Art. 19 Liability
ClinO – see in particular article and annex
- Art. 10-14 Liability and Coverage
- Annex 2 Policy values for liability coverage
ClinO-MD – see in particular article
- Art. 3 Applicable provisions
Code of Obligation – see in particular article
- Art. 60 Claims and time limits
HRO – see in particular article
- Art. 13 Liability coverage
Swiss Code of Obligations:2021 – see in particular article
Art. 60 Right to claim damages