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Document textGeneral document text1ArticlesRegular articles in this version57AnnexesAnnexes and attachments in this version2
Document text1
Articles57
1Chapter 1 General Provisions
Art. 1 – PurposeArt. 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 spe… Direct link
Art. 1a – DefinitionArt. 1a Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Definition In this Ordinance, surplus infor… Direct link
Art. 2 – Applicable provisionsArt. 2 Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Applicable provisions The following provisions… Direct link
Art. 3 – Responsibilities ofproject leader and sponsorArt. 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… Direct link
Art. 4 – Professional qualificationsArt. 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 co… Direct link
Art. 5 – Storage of health-related personal data and biological materialArt. 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 i… Direct link
Art. 5a – Handling of genetic data in connection with insuranceArt. 5a Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Handling of genetic data in connection with… Direct link
1Chapter 2 Research Involving Measures for Sampling of Biological Material or Collection of Health-Related Personal Data from Persons
2Section 1 General Provisions
Art. 6 – Research projectArt. 6 Research project For the purposes of this Chapter, a research project is any project in which biological material is sampled or health-related personal data is collected from a person in order to: a. answer a sci… Direct link
Art. 6a – Completion of the research projectArt. 6a Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Completion of the research project The comp… Direct link
Art. 7 – CategorisationArt. 7 Categorisation 1 A research project comes under Category A if the planned measures for sampling biological material or collecting personal data entail only minimal risks and burdens. 2 A research project comes un… Direct link
Art. 8 – InformationArt. 8 Information 1 In addition to the points specified in Article 16 paragraph 2 HRA, the persons concerned must receive information on: a. the effort involved and the obligations arising from participation; b. their… Direct link
Art. 8a – Information in cases of genetic testingArt. 8a Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Information in cases of genetic testing 1 I… Direct link
Art. 8b – Information in cases of prenatal risk assessmentArt. 8b Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Information in cases of prenatal risk asses… Direct link
Art. 8c – Form of consentArt. 8c Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Form of consent 1 Consent must be signed by… Direct link
Art. 9 – Exceptions to written formArt. 9 Exceptions to written form 1 Information and consent may be provided and documented in a non‑written form if: a. the research project in question comes under Category A, as defined in this Ordinance, and involves… Direct link
Art. 9a – Communication of resultsArt. 9a Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Communication of results 1 The right of the… Direct link
Art. 10 – Consequences of revocation of consentArt. 10 Consequences of revocation of consent 1 If consent is revoked, the biological material and health‑related personal data of the person concerned must be anonymised after data evaluation has been completed. 2 Anon… Direct link
Art. 11 – Research projects in emergency situationsArt. 11 Research projects in emergency situations For research projects in emergency situations, Articles 15–17 ClinOSR 810.305 apply mutatis mutandis. SR 810.305 Direct link
Art. 12Art. 12 Repealed by No I of the O of 7 June 2024, with effect from 1 Nov. 2024 (AS 2024 321). Repealed by No I of the O of 7 June 2024, with effect from 1 Nov. 2024 (AS 2024 321). Direct link
Art. 13 – CoverageArt. 13 Coverage 1 Category A research projects are exempt from the liability coverage requirements specified in Article 20 HRA. 2 For Category B research projects, the policy value shall be set in accordance with Annex… Direct link
2Section 2 Approval Procedure
Art. 14 – ApplicationArt. 14 Application 1 The project leader shall submit the application documents specified in Annex 2 to the responsible ethics committee for review. 2 The ethics committee may request additional information. 3 The spons… Direct link
Art. 15 – Review areasArt. 15 Review areas The responsible ethics committee shall review: a. the completeness of the application; b. the categorisation requested; c. the research project with regard to: 1. scientific quality, in the case of… Direct link
Art. 16 – Procedure and deadlinesArt. 16 Procedure and deadlines 1 The ethics committee shall acknowledge receipt of the application within 7 days and notify the project leader of any formal deficiencies in the application documents. 2 It shall reach a… Direct link
Art. 17 – Multicentre research projectsArt. 17 Multicentre research projects 1 The project leader shall submit the application for a multicentre research project to the lead committee in accordance with Article 47 paragraph 2 HRA. 2 The lead committee shall… Direct link
Art. 18 – ModificationsArt. 18 Modifications 1 Substantial modifications to an approved research project must be approved by the ethics committee before being implemented. Exempt from this requirement are measures which have to be taken immed… Direct link
Art. 19 – Procedure for accompanying examinations involving ionising radiationArt. 19 Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321, 581). Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321, 581). Procedure for accompanying examinat… Direct link
2Section 3 Notifications and Reporting
Art. 20 – Notification of safety and protective measuresArt. 20 Notification of safety and protective measures If immediate safety and protective measures have to be taken during the conduct of a research project, the project leader shall notify the ethics committee of these… Direct link
Art. 21 – Serious eventsArt. 21 Serious events 1 If, in the course of a research project, serious events occur in participants, the research project must be interrupted. 2 A serious event is defined as any adverse event where it cannot be excl… Direct link
Art. 22 – Notification upon completion or premature termination of a research projectArt. 22 Notification upon completion or premature termination of a research project The project leader shall notify the ethics committee of the premature termination or completion of a research project within 90 days. Direct link
Art. 23 – Assessment, notification and reporting on the use of ionising radiationArt. 23 Amended by Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261). Amended by Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force… Direct link
1Chapter 3 Further Use of Biological Material and Health-related Personal Data for Research
2Section 1 General Provisions
Art. 23a – Further useArt. 24 Further use Further use of biological material and health-related personal data is defined as any handling, for research purposes, of biological material already sampled or data already collected, and in particu… Direct link
Art. 24 – AnonymisationArt. 25 Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Anonymisation 1 For the anonymisation of biol… Direct link
Art. 25 – CodingArt. 26 Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Coding 1 Biological material and health-relat… Direct link
Art. 26 – Conditions for breaking the codeArt. 27 Conditions for breaking the code For coded biological material and coded health-related personal data, the code may only be broken if: a. breaking the code is necessary to avert an immediate risk to the health o… Direct link
2Section 2 Informed Consent and Information
Art. 27 – Informed consent for further use of biological material and genetic personal data in uncoded form for a research projectArt. 28 Informed consent for further use of biological material and genetic personal data in uncoded form for a research project 1 The persons concerned must receive written and oral information on: a. the nature, purpo… Direct link
Art. 28 – Informed consent for further use of biological material and genetic personal data in coded form for research purposesArt. 29 Informed consent for further use of biological material and genetic personal data in coded form for research purposes 1 The persons concerned must receive written or oral information on: a. the intended further… Direct link
Art. 29 – Information on the intended anonymisation of biological material and genetic personal data for research purposesArt. 30 Information on the intended anonymisation of biological material and genetic personal data for research purposes The persons concerned must receive written or oral information on: a. the intended anonymisation o… Direct link
Art. 30 – Informed consent for further use of non-genetic health-related personal data in uncoded form for research purposesArt. 31 Informed consent for further use of non-genetic health-related personal data in uncoded form for research purposes 1 The persons concerned must receive written or oral information on: a. the intended further use… Direct link
Art. 31 – Information on the intended further use of non-genetic health-related personal data in coded form for research purposesArt. 32 Information on the intended further use of non-genetic health-related personal data in coded form for research purposes The persons concerned must receive written or oral information on: a. the intended further… Direct link
2Section 3 Approval Procedure and Notification Requirements for Research Projects involving Biological Material and Health-Related Personal Data
Art. 32 – Research projectArt. 33 Research project For the purposes of this Section, a research project is any project in which further use is made of biological material already sampled or health-related personal data already collected in order… Direct link
Art. 33 – Review areasArt. 34 Review areas 1 The responsible ethics committee shall review: Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Amended by No I of the O of 7 June 2024, in force since 1 Nov. 202… Direct link
Art. 34 – Applicable provisionsArt. 35 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:… Direct link
Art. 35 – Notification requirementsArt. 36 Notification requirements 1 The project leader shall notify the ethics committee of a change of project leader in advance. 2 The project leader shall notify the ethics committee of the completion or premature te… Direct link
2Section 4 Approval Procedure and Notification Requirements for further Use of Biological Material and Health-Related Personal Data for Research in the Absence of Informed Consent in accordance with Article 34 HRA
Art. 36 – Review areasArt. 37 Review areas The responsible ethics committee shall review: Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024… Direct link
Art. 37 – Applicable provisionsArt. 38 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 further use or collection accor… Direct link
Art. 38 – ApprovalArt. 39 Approval The approval shall include at least the following information: a. the purpose for which further use may be made of the biological material and the health-related personal data; b. the designation of the… Direct link
Art. 39 – NotificationsArt. 40 Notifications 1 The project leader must notify the ethics committee in advance of any modification to the information given in the approval. 2 The project leader must notify the ethics committee of the completio… Direct link
1Chapter 4 Research Involving Deceased Persons
Art. 40 – Review areasArt. 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 involvin… Direct link
Art. 41 – Applicable provisionsArt. 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:… Current article Direct link
Art. 42 – NotificationsArt. 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 per… Direct link
1Chapter 5 Research involving Embryos and Foetuses from Induced Abortions and from Spontaneous Abortions including Stillbirths
Art. 43 – Informed consentArt. 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 writte… Direct link
Art. 44 – Review areasArt. 45 Review areas The responsible ethics committee shall review: Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024… Direct link
Art. 45 – Applicable provisionsArt. 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:… Direct link
1Chapter 6 Final Provisions
Art. 46 – Updating of AnnexesArt. 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… Direct link
Art. 47 – Transitional provisionsArt. 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… Direct link
Art. 48 – Transitional provisions to the Amendment of 7 June 2024Art. 48a Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321, 343). Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321, 343). Transitional provisions to the A… Direct link
Art. 48a – CommencementArt. 49 Commencement This Ordinance comes into force on 1 January 2014. Direct link
Annexes2
Policy values for liability coverageAnnex 1 (Art. 13) Policy values for liability coverage For Category B research projects involving persons, the policy value shall be at least: a. per person: 250 000 Swiss francs; b. for damage to property: 20 000 Swiss…Direct link
Application documents to be submitted to the responsible ethics committee for the procedureAnnex 2 (Art. 14, 17–19) Application documents to be submitted to the responsible ethics committee for the procedure 1 Application documents for research projects involving the sampling of biological material or the col…Direct link

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