Basic↦Ethics and Laws↦Authorities↦Ethics Committee
What is it? Why is it important?
Switzerland has seven Ethics Committees (EC), each one responsible for their respectively assigned cantons, with swissethics being the umbrella organisation.
ECs are independent bodies made up of a group of selected individuals (e.g. clinicians (physicians, nurses), scientists, lawyers, chaplains/ethicists, patient representatives).
The aim of the EC is to:
- Protect the interest of individuals
- Oversee compliance with applicable ethical standards, regulatory requirements, and guidelines (e.g. the Decleration of Helsinki, the Swiss law, ICH GCP and ISO 14155 guidelines)
According to swissethics, studies are only ethically justified when:
- The dignity of study participants is respected
- The study is of high scientific quality and integrity
- All legal frameworks and applicable guidelines are respected
- The risk-benefit ratio is and remains favourable during study conduct
More
In the event of a multi-centre study, swissethics defines a:
- A Lead-EC: assigned based on the canton from where a study application is submitted
- Local-EC: are EC(s) from participating study site(s) located in cantons outside the jurisdiction of the Lead-EC
The lead EC is responsible:
- For the review and approval of the study application dossier (e.g. includes also research project applications)
- For the review and approval of any amendment(s) during study conduct (e.g. including research project changes)
- To ensure that the rights, safety, and well-being of study participants are protected at all times
The Local-EC is responsible:
- To evaluate the qualification and suitability of the study- or research site (e.g. local staff, infrastructure, participant information)
What do I need to do?
Prior to implementation, all human studies and research projects, must initially be approved by the Ethics Committee (e.g. in a multi-centre study several local ECs are usually involved).
Exceptions are:
- Quality assurance aspects
- Literature reviews
- Case reports (e.g. documentation of an unusual clinical phenomenon in a single patient)
- Research using health-related data that is
- Anonymized (e.g. processes used to ensure data is anonymized must be approved by EC). Data mining/searches that are not done on anonymous data fall under the HRA
- Collected anonymously
- Research conducted on anonymous human biological material
- Opinion polls
As a SP-INV or Site-INV, ensure that the protection and safety of study participants (e.g. risk-benefit) always takes priority over any scientific or financial interest (e.g. conflict of interest).
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.usz.ch
External Links
Swissethics – see in particular
- BASEC: EC submission portal
- Mission statement of swissethics
- List of Swiss ethics committees
- Position papers and guidelines from swissethics
Declaration of Helsinki - see in particular
- Research Ethics Committees
References
ICH GCP E6(R2) – see in particular articles
- Art. 1.27 EC definition
- Art. 1.31 IRB definition
- Art. 3. IRB / EC
ISO 14155:2020 Medical devices (access liable to coast – see in particular annex
- Annex G EC responsibilities
Swiss Law
HRA – see in particular chapters
- Chapter 8 Authorisation, notifications and procedure
- Chapter 9 Research ethics committees
OrgO-HRA – see in particular chapter
- Chapter 1 Research ethics committee