Human Research Ordinance (HRO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 1 Purpose
This Ordinance regulates: a. the requirements for the conduct of human research projects with the exception of clinical trials; and b. the approval and notification procedures for research projects as specified in letter a.
Art. 1a Definition
In this Ordinance, surplus information means results relating to a specific person, in particular incidental findings, which arise in the course of a research project and which are not required either for the conduct thereof or to answer the scientific question.
Art. 1a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 2 Applicable provisions
The following provisions of the Ordinance of 20 September 2013 on Clinical Trials (ClinO) apply mutatis mutandis: a. Article 3 concerning scientific integrity; b. Article 4 concerning scientific quality; c. Article 4a concerning the inclusion of relevant groups of persons.
Art. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). SR 810.305
Art. 3 Responsibilities ofproject leader and sponsor
1 The project leader is responsible for the conduct of the research project in Switzerland and for protection of the participants at the research site. 2 The project leader is also responsible for organising the research project, and in particular for the initiation, management and financing of the project in Switzerland, provided that no other person or institution headquartered or represented in Switzerland takes responsibility for this (sponsor).
Art. 4 Professional qualifications
1 The project leader responsible for a research project must: a. be entitled to practise the profession under his or her own responsibility that specifically qualifies him or her to conduct the research project in question; b. have the training and experience required to conduct the research project in question; c. be conversant with the legal requirements for research projects or be able to ensure compliance by calling in appropriate expertise; d. have appropriate knowledge and skills in the areas of data security and data protection or be able to ensure compliance by calling in appropriate expertise. 2 The other persons conducting the research project must have the professional knowledge and experience appropriate to the activities in question.
Para. 1 let. d — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 5 Storage of health-related personal data and biological material
1 Any person who stores health-related personal data for research must take appropriate operational and organisational measures to protect it, and in particular: a. restrict the handling of the health-related personal data to those persons who require this data to fulfil their duties; b. prevent unauthorised or accidental disclosure, alteration, deletion and copying of the health-related personal data; c. document all processing operations which are essential to ensure traceability. 2 Any person who stores biological material for research must, in particular: a. comply with the principles set out in paragraph 1 mutatis mutandis; b. ensure that the technical requirements are met for appropriate storage of the biological material; here, nationally and internationally recognised guidelines must be consulted; c. make available the resources required for storage.
Para. 2 let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 5a Handling of genetic data in connection with insurance
In connection with insurance, Articles 42–44 of the Federal Act of 15 June 2018 on Human Genetic Testing (HGTA) apply to the handling of genetic data from research projects.
Art. 5a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). SR 810.12