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. 41 Review areas
The ethics committee shall review: a. the completeness of the application; b. the scientific quality; c. compliance with the requirements for consent (Art. 36 HRA); d. for research projects involving deceased persons undergoing artificial respiration: the need to involve them in the research project (Art. 37 para. 2 HRA) and compliance with the requirement for independence of the persons involved in the determination of their death (Art. 37 para. 3 HRA); e. compliance with the requirements for the storage of biological material or health-related personal data; f. compliance with the prohibition of commercialisation (Art. 9 HRA); g. the professional qualifications of the project leader and the other researchers.
Art. 42 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.
Art. 43 Notifications
1 The project leader must notify the ethics committee in advance of the following modifications to the research project: a. change of project leader; b. for research projects involving deceased persons undergoing artificial respiration: substantial modifications to the protocol. 2 The project leader shall notify the ethics committee of the completion or premature termination of the research project within 90 days.