Which data collections in human research are subject to authorisation by an ethics committee and when is the consent of the participants or their information on the right to dissent required? This question is addressed in the new guidance document published by swissethics. It provides structured explanations on how registry data are used for research purposes. It is recommended that a so-called registry protocol/regulation be drawn up when a registry is established and voluntarily submitted to the ethics committee for a preliminary examination. If a research project with data from the registry is then carried out at a later date, the ethics committee will be able to proceed more speedily.

A new section will be set up in BASEC for the submission of the register protocol/regulation. swissethics will inform all interested parties as soon as this has been released and the submission can begin.

The guidance document can be accessed under the following link (in German and French).