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. 56 Registration
1 Authorised clinical trials must be recorded in a public register. The Federal Council shall define the clinical trials in more detail and may specify exemptions from mandatory registration; in doing so, it shall be guided by recognised international regulations. 2 It shall designate the register, provide information on access thereto and specify the content of registration, as well as notification requirements and the notification procedure. In doing so, it shall have regard to recognised international regulations and if possible take existing registers into consideration. 3 It may: a. entrust public- or private-law organisations with the establishment and management of the register; b. specify that the results of registered research projects must be published on a recognised platform.
Para. 1 — Second sentence amended by Annex of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1). Para. 3 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. 56a Cantonal information system
1 The cantons shall operate a shared information system for the conduct of authorisation and notification procedures, the transmission of reports and the supervision of research projects. 2 The system shall contain data, including personal data on administrative or criminal proceedings and sanctions or on health, which is necessary for the conduct of authorisation and notification procedures and for reporting and supervision in accordance with this Act. 3 The cantons shall ensure that the information system is compatible with the Medical Devices Information System of the Swiss Agency for Therapeutic Products and with the European database on medical devices (Eudamed). 4 The Federal Council may specify that: a. the data referred to in paragraph 2 concerning clinical trials with medical devices is to be automatically aligned with the Medical Devices Information System of the Swiss Agency for Therapeutic Products or with Eudamed; b. any data referred to in paragraph 2 which is not sensiti
Art. 56a — Inserted by Annex of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961; BBl 2019 1).
Art. 57 Duty of confidentiality
Persons responsible for the enforcement of this Act have a duty to maintain confidentiality.
Art. 58 Processing of personal data
In discharging their duties, ethics committees and the other enforcement bodies are entitled to process personal data. Sensitive personal data may be processed, insofar as this is necessary.
Art. 59 Disclosure of data
1 Where no conflicting private interest of overriding importance exists, data may be disclosed to: a. the federal and cantonal agencies responsible for enforcement of this Act, and to public- or private-law organisations and persons if they require the data to fulfil the duties assigned to them under this Act; b. criminal investigation authorities if the data is required to prosecute or prevent a felony or an offence under this Act. 2 Where no conflicting private interest of overriding importance exists, data may, in individual cases, following a written request, be disclosed to: a. civil courts if the data is required to judge a court case; b. criminal courts and criminal investigation authorities if the data is required to investigate a felony or misdemeanour. 3 Data which is of general interest and relates to the application of this Act may be published. The data subjects must not be identifiable. 4 In other cases, data may be disclosed to third parties as follows: a. data not relat
Art. 60 Transmission of data to foreign authorities and international organisations
1 Confidential data may only be transmitted to foreign authorities and institutions or to international organisations if: a. this is required by agreements under international law or resolutions passed by international organisations; b. this is necessary to avert an imminent danger to life or health; or c. this would enable serious offences under this Act to be exposed. 2 The Federal Council shall regulate responsibilities and the procedures for exchanging data with foreign authorities and institutions and with international organisations.
Art. 61 Evaluation
1 The FOPH is responsible for assessing the effectiveness of this Act. 2 The Federal Department of Home Affairs shall report to the Federal Council on the results of the evaluation and submit proposals for further action.