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. 44 Informed consent
1 For research projects involving embryos and foetuses from induced abortions and from spontaneous abortions including stillbirths, the pregnant woman or the couple concerned must receive written and oral information on: a. the use of the embryo or foetus for research purposes; b. their right to withhold or to revoke their consent at any time without giving reasons; c. measures to protect the biological material and the personal data; d. the handling of the embryo or foetus after completion of the research. 2 The information may be additionally presented in a non-textual form. 3 The form of consent is governed by Article 8c. 4 Article 9 applies mutatis mutandis. 5 The consequences of revocation of consent are governed by Article 10.
Para. 3 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 4 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 5 — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 45 Review areas
The responsible ethics committee shall review: a. the completeness of the application; b. the scientific quality; c. compliance with the requirements for informed consent, and, where applicable compliance with the requirements for consent in electronic form (Art. 8c para. 3 let. a–c); d. for research projects involving embryos and foetuses from induced abortions: compliance with the requirements specified in Article 39 paragraphs 1, 2 and 4 HRA; e. compliance with the prohibition of commercialisation (Art. 9 HRA); f. compliance with the requirements concerning the storage of biological material or health-related personal data; g. the professional qualifications of the project leader and the other researchers; h. other areas, where this is necessary to assess the protection of the pregnant woman or the couple concerned.
Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). let. c — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 46 Applicable provisions
The following provisions apply mutatis mutandis: a. for the submission of the application: Article 14; b. for the procedure and deadlines: Article 16; c. for multicentre research projects: the procedure specified in Article 17; d. for notification requirements: Article 36.