Concept↦Ethics and Laws↦Regulatory Advice Meeting↦Ethics Clarification
What is it? Why is it important?
The study SP-INV or a Site-INV can ask the Ethics Committee (EC) to clarify questions or issues related to study planning and conduct.
The EC can provide support:
- By deciding whether a planned research project falls under the HRA act or not. The EC can issue a written statement confirming that the project does not need EC approval
- By assigning the risk category to a study
- Concerning administrative tasks, such as required documents to be submitted for study approval
- Regarding ethical questions and issues relevant to study planning and conduct
What do I need to do?
As a SP-INV and Site-INV:
- Access the swissethics webpage
- Log into BASEC, if applicable create an account
- Click on “Submit an application”
- Go to “Clarification of Responsibility / Support Request”
- Fill in the form
- Submit your application
As an alternative, each of the seven local ECs have secretarial offices that can be contacted by phone. They will be able to either answer your questions or advice you on how to proceed.
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 portal for EC submission