Dealing with an ethics committee

An ethics committee is always required for the performance of a clinical investigation, i.e., when a treatment deviates from standard of care (pre-market device or off-label use), but it is also mandatory for any scientific publication.

It is often something feared by companies or, if not, something that wastes a lot of time due to the long bureaucratic time and the difficulties in interfacing with institutions. Once you have identified the clinical investigation center, however, you only need to draft a meaty list of documents and talk to the committee secretary. If you need help with this, you can message me.