Implementation: guiding principles for registers in human research
Advisory opinion of the
ethics committees on registers, biobanks and research projects in accordance
with Art. 51 HFG
The pure creation of data registries or biobanks is not formally subject to authorisation under the HRA. However, projects that re-use these data and biological samples must generally be approved by an ethics committee. The ethics committees now offer a preliminary examination of the data registries and biobanks. This can ensure that data protection is correctly maintained and that the consent of participants in the research is obtained in accordance with the legal and ethical requirements. The aim is that after the preliminary examination, all projects arising from these data registries or biobanks can be approved by the ethics committees smoothly.
Obtaining this "advice" is voluntary. It is an advisory function of the ethics committee (in accordance with Art. 51 HFG) and it is invoiced according to the time and efforts of the ethics committee. The documents to be submitted via BASEC for the preliminary examination can be found in the BASEC portal (see the form «Advice on ethical questions/comments on research projects not subject to the HRA» (link)). Similarly, "advices" of the ethics committees can be obtained for example on research projects done abroad.