Art. 1 Purpose
This Ordinance regulates:
- a.
- the requirements for the conduct of human research projects with the exception of clinical trials; and
- b.
- the authorisation and notification procedures for research projects as specified in letter a.
810.301
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
of 20 September 2013 (Status as of 1 September 2023)
The Swiss Federal Council,
on the basis of the Human Research Act of 30 September 20111 (HRA),
ordains:
This Ordinance regulates:
The provisions concerning scientific integrity and scientific quality set out in Articles 3 and 4 of the Ordinance of 20 September 20132 on Clinical Trials (ClinO) apply mutatis mutandis.
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 leader is also responsible for organising the research project, and in particular for the initiation, management and financing of the project in Switzerland, provided that no other person or institution headquartered or represented in Switzerland takes responsibility for this (sponsor).
1 The project leader responsible for a research project must:
2 The other persons conducting the research project must have the professional knowledge and experience appropriate to the activities in question.
1 Any person who stores health-related personal data for research must take appropriate operational and organisational measures to protect it, and in particular:
2 Any person who stores biological material for research must, in particular:
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:
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 under Category B if the planned measures entail more than only minimal risks and burdens.
3 Sampling biological material or collecting health-related personal data entails minimal risks and burdens if the measures, in terms of intensity and quality, and taking into account the vulnerability of the participants and the specific circumstances, have only a slight and temporary impact on the participants' health. In particular, minimal risks and burdens may be associated with:
3 Amended by Annex 2 No 1 of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).
1 In addition to the points specified in Article 16 paragraph 2 HRA, the persons concerned must receive information on:
2 If the intention exists to make further use for research of the biological material sampled or the health-related personal data collected, the persons concerned must also receive information on the points specified in Articles 28−32.
3 The information may be provided in stages. It may be additionally presented in a non-textual form.
4 Appropriate measures must be taken to ensure that the persons concerned have understood the essential elements of the information provided.
1 Information and consent may be provided and documented in a non‑written form if:
2 In individual cases, information may be provided and consent granted in a non‑written form if:
3 In individual cases, the requirement to provide information in written form may be waived if:
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 Anonymisation of the biological material and personal data may be dispensed with if:
3 Persons revoking consent must be offered any follow-up care required to protect their health.
For research projects in emergency situations, Articles 15-17 ClinO5 apply mutatis mutandis.
Any person who proves that:
shall be exempt from liability under Article 19 paragraph 1 HRA.
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 1.
3 The liability coverage must cover damage occurring up to 10 years after the completion of the research project.
4 In addition, Article 11, Article 13 paragraph 1 and Article 14 ClinO6 apply mutatis mutandis.
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 sponsor may submit the application instead of the project leader. In this case, the sponsor assumes the obligations of the project leader as specified in Articles 17-23. The application documents must be co-signed by the project leader.
The responsible ethics committee shall review:
7 Term in accordance with Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261). This modification has been made throughout the text.
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 decision within 30 days after acknowledgement of receipt of the formally correct application documents.
3 If the ethics committee requests additional information in accordance with Article 14 paragraph 2, the clock shall be stopped until this information has been received.
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 acknowledge receipt of the application within 7 days and at the same time notify the project leader whether the application documents submitted are formally in order.
3 At the request of the lead committee, the project leader shall submit the required number of copies of the application documents specified in Annex 2 to the ethics committees responsible at the other research sites (ethics committees concerned). These shall review the local conditions and inform the lead committee of their assessment within 15 days.
4 The lead committee shall reach a decision within 45 days of acknowledging receipt of the formally correct application. It shall inform the ethics committees concerned of its decision.
1 Significant changes to an authorised research project must be authorised by the ethics committee before being implemented. Exempt from this requirement are measures which have to be taken immediately in order to protect the participants.
2 The project leader shall submit to the ethics committee any application documents specified in Annex 2 which are affected by the change. At the same time, the project leader shall provide information on the reasons for the change.
3 The following are considered to be significant changes:
4 The ethics committee shall reach a decision on significant changes within 30 days. Article 16 applies mutatis mutandis.
5 For the authorisation procedure in the case of significant changes to authorised multicentre research projects, Article 17 applies mutatis mutandis.
1 In the case of investigations involving radiation sources, the project leader shall additionally submit to the responsible ethics committee the documents specified in Annex 2 number 2. Subject to the provisions of the following paragraphs, the authorisation procedure is governed by Articles 14-18.
2 The project leader shall additionally submit to the FOPH the application documents specified in Annex 2 number 3, informing the ethics committee at the same time if the effective dose per person, taking the uncertainty factor into account, is more than 5 mSv per year and:
3 The FOPH shall deliver an opinion for the ethics committee on compliance with radiological protection legislation and on the dose estimation.
4 The ethics committee shall grant authorisation if:
5 It shall reach a decision in this case within 45 days after acknowledgement of receipt of the formally correct application documents. It shall inform the FOPH of its decision.
8 Term in accordance with Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261). This modification has been made throughout the text.
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 measures, and of the circumstances necessitating them, within 7 days.
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 excluded that the event is attributable to the sampling of biological material or the collection of health-related personal data, and which:
3 If necessary in order to guarantee participants' safety and health, further events are to be designated as serious in the protocol or at the request of the responsible ethics committee.
4 The project leader shall notify the ethics committee of a serious event within 7 days. In addition, the project leader shall report to the committee on the connection between the event and the collection of health-related personal data or the sampling of biological material. At the same time, he or she shall submit proposals concerning the next steps to be taken.
5 If a serious event occurs in connection with an investigation involving a radiation source on which the FOPH has delivered an opinion in accordance with Article 19, this must be additionally reported to the FOPH within 7 days.
6 The ethics committee shall reach a decision on the continuation of the research project within 30 days after receipt of the report.
The project leader shall notify the ethics committee of the discontinuation or completion of a research project within 90 days.
1 In the case of investigations using radiation sources, the project leader shall assess compliance with the dose guidance value under Article 45 of the Radiological Protection Ordinance of 26 April 201710.
2 He or she shall give notify the competent ethics committee if the permitted dose guidance value within seven working days of the information coming to light.
3 The competent ethics committee may obtain technical advice from the FOPH in order to assess the dose calculation or the dose estimate and to decide what further measures are required.
4 Within a year of completing or discontinuing a research project which included investigations involving radioactive sources, the project leader shall submit to the FOPH a final report including all information of relevance for radiological protection, and in particular a retrospective dose estimation by the participants.
5 Routine nuclear medicine examinations involving authorised radiopharmaceuticals are exempt from the reporting requirement under paragraph 4.
6 Within the framework of the opinion delivered in accordance with Article 19, or on request, the FOPH may specify further exemptions from the reporting requirements.
9 Amended by Annex 11 No 5 of the Radiation Protection Ordinance of 26 Apr. 2017, in force since 1 Jan. 2018 (AS 2017 4261).
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 particular:
1 For the anonymisation of biological material and health-related personal data, all items which, when combined, would enable the data subject to be identified without disproportionate effort, must be irreversibly masked or deleted.
2 In particular, the name, address, date of birth and unique identification numbers must be masked or deleted.
1 Biological material and health-related personal data are considered to be correctly coded in accordance with Article 32 paragraph 2 and Article 33 paragraph 2 HRA if, from the perspective of a person who lacks access to the key, they are to be characterised as anonymised.
2 The key must be stored separately from the biological material or personal data and in accordance with the principles of Article 5 paragraph 1, by a person to be designated in the application who is not involved in the research project.11
11 Amended by Annex 2 No II 95 of the Data Protection Ordinance of 31 Aug. 2022, in force since 1 Sept. 2023 (AS 2022 568).
For coded biological material and coded health-related personal data, the code may only be broken if:
1 The persons concerned must receive written and oral information on:
2 The information may be additionally presented in a non-textual form.
3 Consent must be given in writing.
4 The exceptions to written form are governed by Article 9 mutatis mutandis.
1 The persons concerned must receive written or oral information on:
2 Consent must be given in writing; the exceptions are governed by Article 9 mutatis mutandis.
The persons concerned must receive written or oral information on:
1 The persons concerned must receive written or oral information on:
2 Consent must be given in writing; the exceptions are governed by Article 9 mutatis mutandis.
The persons concerned must receive written or oral information on:
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 to answer a scientific question.
1 The ethics committee shall review:
2 In this process, it shall take into account existing authorisations from ethics committees with regard to the biological material or the health-related personal data.
The following provisions apply mutatis mutandis:
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 discontinuation of the research project within 90 days.
The ethics committee shall review:
The following provisions apply mutatis mutandis:
The authorisation shall include at least the following information:
1 The project leader must notify the ethics committee in advance of any changes to the information given in the authorisation.
2 The project leader must notify the ethics committee of the completion or discontinuation of the collection process within 90 days.
The ethics committee shall review:
The following provisions apply mutatis mutandis:
1 The project leader must notify the ethics committee in advance of the following changes to the research project:
2 The project leader shall notify the ethics committee of the completion or discontinuation of the research project within 90 days.
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:
2 The information may be additionally presented in a non-textual form.
3 Consent must be given in writing. The consequences of revocation of consent are governed by Article 10.
4 The exceptions to written form are governed by Article 9 mutatis mutandis.
The ethics committee shall review:
The following provisions apply mutatis mutandis:
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.
1 Research projects as defined in Chapter 2 which were granted authorisation before 1 January 2014 are considered to be Category B research projects.
2 On request, the authority which authorised 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 201312.
4 The provisions of this Ordinance are applicable:
5 The responsible ethics committee shall make a decision on applications concerning research projects not subject to authorisation under existing law, submitted in accordance with Article 67 paragraph 2 HRA, within six months after acknowledgement of receipt of the formally correct application documents.
This Ordinance comes into force on 1 January 2014.
(Art. 13)
For Category B research projects involving persons, the policy value shall be at least:
(Art. 14, 17-19)
14 This form can be obtained [in French/German] from the Federal Office of Public Health, Radiological Protection Division, CH-3003 Bern; it can also be accessed online at: www.bag.admin.ch > Themen > Strahlung, Radioaktivität und Schall.