On 25 May 2018, the new General Data Protection Regulation (GDPR), will enter into force in the EU, which will also require immediate action in Switzerland for further, smooth international data traffic. In Switzerland, the Federal Act on the Data Protection (FADP, SR 235.1) is currently under revision. Various cantons will also adapt their data protection legislation.

In human research, this affects all internationally active institutions and companies that collect and process personal data from EU residents or send data from Swiss citizens abroad (EU). Internationally compatible solutions must therefore be found for data protection.

The required information to the patients regarding changes in the data protection is possible for example on a temporary basis by means of additional information documents. These must be submitted separately to the competent ethics committees. In the medium term, the chapter on the confidentiality in the template of swissethics will be adapted in such a way that no further use of additional information documents will be required. However, this will only be possible after the entry into force of the revised Federal Act on Data Protection (date still unknown). swissethics will provide more information in due course.