Stem Cell Research Ordinance (SCRO)
Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325).
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 17 Application
When approval is sought for the conduct of a research project involving embryonic stem cells (Art. 11 StRA), the following documents must be submitted to the competent ethics committee for review: a. complete documentation for the research project; b. a statement of the reasons why equivalent findings could not also be obtained in a different way, in particular through the use of iPSC; c. the information sheet and the form for the declaration of consent, if embryonic stem cells have to be derived for the research project.
Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325). let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325).
Art. 18 Review of the application
1 The ethics committee shall review whether: a. the documents are complete; b. the conditions specified in the StRA for the conduct of a research project involving embryonic stem cells are met. 2 If the research project is to be conducted at several centres, it shall suffice if approval is granted under the regular procedure by the competent ethics committee at the first centre; decisions may be reached by the other ethics committees concerned under a simplified procedure. The project leader must submit the approval granted by the competent ethics committee at the first centre. 3 For the evaluation of the research project, the ethics committee may consult experts and request additional documents from the project leader.
Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325).
Art. 19 Period
1 The ethics committee shall issue its decision within 30 days. 2 If the ethics committee consults experts or requests additional documents from the project leader, the period shall begin as soon as the experts’ comments or the documents have arrived. 3 The ethics committee shall notify the project leader of the beginning of the period.
Art. 19 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325).
Art. 20 Initiation of the research project
1 Prior to the initiation of the research project, the project leader shall notify the FOPH thereof and submit: a. the title of the research project, if the FOPH has the project documents at its disposal in connection with the licensing procedure under Article 5 or 13; b. the complete documentation for the research project, as submitted to the competent ethics committee in accordance with Article 17, together with this committee’s approval, if embryonic stem cells available in Switzerland are to be used for the project. 2 The FOPH may request additional documents from the project leader. 3 Within 15 days of receipt of the notification or the necessary documents, the FOPH shall assign a reference number to the research project, provided that it has no objections. It shall inform the project leader of the number. 4 After the communication of the reference number, the research project may be initiated.
Para. 1 let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325).
Art. 21 Re-evaluation and withdrawal of approval
1 The ethics committee may re-evaluate a research project and if appropriate withdraw its approval, if this is necessitated by new scientific findings and a resultant change in the ethical assessment. 2 It shall notify the project leader and the FOPH immediately of the withdrawal of its approval. 3 It shall inform the FOPH immediately of any irregularities in the conduct of the research project.
Art. 21 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325). Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325). Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 325).