Publication of the updated templates

Instructions on the procedure for submitting applications before 1 November 2024

The revision of the ordinances of the Human Research Act (HRA), which will come into force on November 1, 2024, requires numerous adjustments for investigators and authorities. The most important aspects of the revision concern the «protection of participants» and the improvement of the «framework conditions for research».

The «protection of the participants» includes aspects on informed consent, information on incidental findings and the exercise of the right to know or not to know, aspects of genetics, representativeness, liability provisions and transparency requirements (the latter only mandatory from March 1, 2025). The improvement of the «framework conditions for research» the use of e-consent, clarification of the definition of coding/anonymisation, and harmonisation and compatibility with international requirements for multi-centre international clinical trials (mainly adjustments in line with EU legislation). The re-categorisation of clinical trials from category C to B is possible under certain conditions. New deadlines apply for submitting applications to both authorities, i.e. Swissmedic and the Ethics Committee. Further requirements are presented here.

swissethics has incorporated all these aspects into the templates for writing study protocols and participants information documents. The templates will be available in advance on the swissethics website in the national languages from September 16, and can be used for applications submitted after November 1, 2024 (or shortly before, according with approval timelines). The guidance document on e-consent will also be valid as of this date. The currently valid templates will remain available until October 31, and can be used (only) until that date.

The transition procedure for clinical trials that are also submitted to Swissmedic has been agreed in close cooperation with Swissmedic: As a general rule, applications submitted before November 1, but which can only be approved after November 1, can still be approved under the old law. This is provided that the requirements under the new ordinances are subsequently submitted with an amendment to the protocol, before the first participant is included in the clinical trial. Authorisation under the new ordinances is therefore still required for clinical trials according to ClinO. This similarly applies to research projects conducted according to HRO, if the requirements of the revised ordinance apply to concerned research project (e.g. if they concern genetics aspects, etc.).

The corresponding updated submission forms in BASEC will be published on November 1, 2024. Applicants can use the current forms until 31 October, after which there will be an automatic transition to the updated forms. Data or documents uploaded on the forms but not submitted to the Ethics Commission before 31 October will not be lost. They will be automatically transferred to the updated forms on 1 November.

Consult the Swissmedic website for further information on clinical trials and the FOPH website, which provides a set of slides jointly developed and published by the FOPH, swissethics and Swissmedic (Slideset on the amendments to the ordinances on the HRA and StRA).