Human Research Ordinance (HRO)

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In The Matter OfHuman Research Ordinance (HRO)
Exhibit A
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English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

Art. 47 Updating of Annexes

The Federal Department of Home Affairs may update the Annexes in accordance with international or technical developments. It shall undertake updates which may give rise to technical barriers to trade in consultation with the Federal Department of Economic Affairs, Education and Research.

Art. 48 Transitional provisions

1 Research projects as defined in Chapter 2 which were granted approval before 1 January 2014 are considered to be Category B research projects. 2 On request, the authority which approved the research project before 1 January 2014 may assign the research project to Category A. In this case, the liability, coverage and notification requirements are governed by the new law. 3 The ethics committee shall make the decision specified in paragraph 2 according to the simplified procedure specified in Article 6 of the HRA Organisation Ordinance of 20 September 2013. 4 The provisions of this Ordinance are applicable: a. to the assessment of substantial modifications to research projects as specified in Chapter 2; b. to notifications concerning research projects as specified in Chapters 3–5. 5 The responsible ethics committee shall make a decision on applications concerning research projects not subject to approval under existing law, submitted in accordance with Article 67 paragraph 2 HRA, withi

Para. 3 — SR 810.308

Art. 48a Transitional provisions to the Amendment of 7 June 2024

1 Article 23a does not apply to research projects approved before the Amendment of 7 June 2024 comes into force. 2 For research projects approved before the before the Amendment of 7 June 2024 comes into force, the liability requirements are governed by the previous law.

Art. 48a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321, 343).

Art. 49 Commencement

This Ordinance comes into force on 1 January 2014.