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. 51 Duties
1 Within the framework of their responsibilities under Chapter 8, ethics committees shall assess whether research projects and the conduct thereof comply with the ethical, legal and scientific requirements of this Act. In particular, they shall assess whether the protection of the persons concerned is guaranteed. 2 They may advise researchers in particular on ethical questions and, if so requested by the researchers, comment on research projects not subject to this Act, and specifically projects carried out abroad.
Art. 52 Independence
1 Ethics committees shall exercise their duties in a professionally independent manner, without being subject to instructions from the supervisory authority in this regard. 2 The members of ethics committees shall disclose their interests. Each ethics committee shall maintain a publicly accessible register of interests. 3 Members who are interested parties shall not participate in the assessment and decision procedures.
Art. 53 Composition
1 Ethics committees must be composed in such a way that they have the professional skills and experience required to discharge their duties. The members must include: a. experts in various disciplines, in particular medicine, ethics and law; and b. at least one person representing patients. 2 Ethics committees may call in external specialists to serve as experts. 3 The Federal Council shall enact additional regulations concerning the composition of ethics committees and the requirements to be fulfilled by their members. In doing so, it shall have regard to recognised international regulations.
Para. 1 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. 54 Organisation and financing
1 Each canton shall designate the ethics committee responsible for its territory and appoint the members thereof. It shall oversee the activities of the ethics committee. 2 Each canton has at most one ethics committee. Several cantons may appoint a joint ethics committee or agree that one canton's ethics committee is also to be responsible for other cantons. 3 The Federal Council may issue guidelines concerning the minimum number of research projects to be assessed by an ethics committee per year. It shall first consult the cantons. 4 Each ethics committee shall have a scientific secretariat. Details of the organisation and working methods are to be publicly accessible in by-laws. 5 The canton shall assure the financing of the ethics committee. It may make provision for the charging of fees.
Art. 55 Coordination and information
1 The Federal Office of Public Health (FOPH) is responsible for coordination between ethics committees and with other supervisory authorities. It may delegate this responsibility to third parties. 2 Ethics committees shall report annually to the FOPH on their activities, in particular on the type and number of research projects assessed and on the processing periods. 3 The FOPH shall publish a list of ethics committees and inform the public regularly about their activities. 4 In consultation with the ethics committees and other supervisory authorities concerned, it may issue recommendations for appropriate harmonisation of procedures and of assessment practice.