Development↦Management↦Study Approval↦Ethics Committee
What is it? Why is it important?
The main responsibility of the Ethics Committee (EC) is to protect the rights, safety and well-being of study participants. Several ECs exist in Switzerland. Swissethics is the umbrella organisation.
All human studies need EC approval prior to implementation.
Exceptions are projects using anonymised biological material, or anonymously collected or anonymised health related data.
- Anonymization procedures must be defined and approved by EC
- Even though no EC approval is required, a declaration of no objection from EC can be helpful for publication
Studies must be categorised (A, B, C) prior to EC submission.
- The category will decide which documents to submit to the EC for evaluation and approval
- The SP-INV makes an initial categorisation
- The EC has the final decision on how the study should be categorised
- Instructions on how to classify a study can be found on the KOFAM Website
What do I need to do?
Submit to the EC as soon as study required documents are finalised.
Documents to be submitted depend on the study:
- Ordinance: Clinical Trial (ClinO) or Research Project (HRO)
- Type: medicinal or transplant products, medical device, other interventions, studies including radiation, etc.
- Category: A, B, C
- Involved sites: mono- or multi-centre
- KOFAM: tool to categorize your study
- BASEC: EC submission portal
List of required documents to be submitted to the EC can be found in the Annex of the respective law applicable to your study (ClinO, HRO). Always use currently released templates from swissethics.
For submission on the BASEC portal, you need to:
- Create a personal login
- Upload all documents needed for the EC to evaluate your application
For more information refer to Ethics and Laws in this Study Guide.
In the event of a multi-centre study:
- The EC to whom SP-INV site is affiliated becomes the lead EC
- The SP-INV submits through BASEC study documents for all study sites
- Competent ECs from participating sites can access study documents through BASEC
EC evaluates the study and can:
- Approve the study as submitted without further adaptations
- Only approve the study based on required adaptations, (e.g. additional information, changes to documents
- Not approve the study
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
swissethics - see in particular
- BASEC: the EC submision portal
KOFAM (SNCTP) - see in particular
- The categorisation of human research projects
OrgO-HRA – see in particular chapter
- Ch. 1 Research and EC
HRA – see in particular article
- Art. 2 Scope of the law
ClinO – see in particular articles and annex
- Art. 24-29 Ethic Committee submission, timelines and approval process including multi-centre studies and studies with tadiation source
- Annex 3 ECsubmission documents
HRO – see in particular articles and annex
- Art. 14-19 Ethic Committee submission, timelines and approval process including multi-centre studies and studies with radiation source
- Annex 2 EC submission documents