When is consultation by an ethics committee sufficient?

... and when do I have to involve which authorities?

Consultation with an ethics committee is required under professional law if doctors wish to conduct biomedical research on humans.

This includes clinical investigations, epidemiological studies with personal data, observational studies as well as prospective and retrospective data analyses. An ethics committee consults on professional ethics and professional law issues to ensure that the research complies with the applicable regulations and is ethically justifiable.

Authorities must be involved when clinical investigations of medicinal products or medical devices are involved, especially if invasive or stressful measures are planned, if a product has not yet been authorised or if it is to be investigated in an area other than that for which it is authorised. In such cases, a favourable evaluation by an ethics committee is required in accordance with the special legal provisions, such as the guidelines and regulations of the European Medicines Agency (EMA) for the authorisation and supervision of medicinal products for human use or for the conduct of clinical investigations of medicinal products or the EU Regulation on medical devices (2017/745) or on in vitro diagnostic medical devices (2017/746) and, in Germany, the Medical Devices Implementation Act (MPDG). In addition, higher federal authorities such as the Paul Ehrlich Institute (PEI) or the Federal Institute for Drugs and Medical Devices (BfArM) must be involved in the process

Can we support you too? You are welcome to arrange a first non-binding appointment here.