Human Research Act (HRA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 45 Mandatory authorisation
1 Authorisation from the responsible ethics committee is required for: a. conducting a research project; or b. making further use of biological material or health-related personal data for research purposes in cases where consent has not been obtained or information on the right to dissent has not been provided (Art. 34). 2 Authorisation is granted if the ethical, legal and scientific requirements of this Act are met. The decision must be available within two months of submission of the application. The Federal Council may: a. specify shorter, risk-adapted maximum limits for processing periods; b. adjust the processing periods, if this is required by recognised international regulations. 3 The Federal Council may make changes to research projects subject to authorisation. In doing so, it shall have regard to recognised international regulations.
Para. 2 let. b — Amended by Annex of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 46 Notification and information requirements
1 The Federal Council may specify notification or information requirements, in particular with regard to: a. the completion or discontinuation of a research project; b. adverse events observed in connection with a research project; c. the occurrence of circumstances during the conduct of a research project which could affect the safety or health of the participants. 2 In doing so, it shall have regard to recognised international regulations.
Art. 47 Responsible ethics committee
1 The responsible ethics committee is that of the canton in whose territory the research is conducted. 2 If a research project is carried out according to a standard protocol, but in different cantons (multicentre research project), authorisation is required from the ethics committee which is responsible at the site of activity of the project coordinator (the lead committee). 3 In order to assess whether the professional and operational requirements are fulfilled in other cantons, the lead committee shall seek the opinion of the ethics committees concerned. It shall be bound by their opinion. 4 Paragraphs 2 and 3 apply mutatis mutandis to authorisation for the use in accordance with Article 34 of biological material and health-related personal data of which further use is made or which are collected according to a standard protocol, but in different cantons.
Art. 48 Official measures
1 If the safety or health of the persons concerned is at risk, the ethics committee may revoke or suspend its authorisation or make the continuation of the research project subject to additional conditions. 2 The ethics committee may request information or documentation from the holder of the authorisation. This must be provided or made available free of charge. 3 The competent federal and cantonal authorities retain the right to take measures. 4 The authorities and ethics committees shall keep each other informed and coordinate their measures.
Art. 49 Procedure
1 The documents for the authorisation and notification procedures, and for reporting and supervision, shall be submitted to the cantonal information system referred to in Article 56a. 1bis The Federal Council shall specify requirements for the procedure so as to ensure consistent enforcement and the implementation of national and international regulations. It may stipulate that the submission of applications, correspondence and the publication of decisions must be effected electronically. 2 In particular for research projects involving biological material and genetic data in accordance with Article 32, or non-genetic health-related personal data in accordance with Article 33, it may specify less stringent procedural requirements. 3 Cantonal procedural law otherwise applies.
Para. 1 — Amended by Annex of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 1bis — Inserted by Annex of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 50 Right of appeal
1 The procedure for appeals against ethics committee decisions is governed by cantonal procedural law and the general provisions concerning the administration of federal justice. 2 The appealing party may not file an appeal based on substantive inappropriateness.