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.
Section 1 General Provisions
Art. 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 scientific question; or b. make further use for research purposes of the biological material or the health-related personal data.
Art. 6a Completion of the research project
The completion of a research project under this Chapter is marked by the last collection of health-related personal data or the last sampling of biological material in a research project, in the absence of provisions to the contrary in the protocol.
Art. 6a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 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 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: a. surveys and observations; b. peripheral venous or capillary blood sampling and skin punch biopsies of limited extent; c. removing or collecting bodily substances without invasive interventions (in particular, saliva, urine and stool samples); d. taking swabs; e. magnetic resonance imaging scans without a contrast medium, u
Para. 3 let. f — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 3 let. f let. 2 — SR 812.213
Art. 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 right to withhold or to revoke their consent without giving reasons; c. the consequences of revoking consent to further use of the biological material and personal data collected up to this point; d. their right to receive information at any time in response to further questions; dbis. the possibility of surplus information arising, and the significance of the discovery of surplus information and the significance of exercising one’s right to know or not to know; e. their right to be informed of results concerning their health, and their right to forgo such information or to designate a person who is to take this decision for them; f. the measures envisaged to cover any damage arising from the research project, including the procedure in the event of a claim; g. the main sources of financin
Para. 1 let. dbis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 4 let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 8a Information in cases of genetic testing
1 If, when presymptomatic genetic testing, prenatal genetic testing, or testing for family planning purposes (Art. 3 let. e, g and i HGTA) is conducted, results arise which concern the health of the person concerned, he or she must additionally receive information on the following: a. the purpose, nature and significance of the test; b. the frequency and nature of the disorder screened for; c. medical, psychological and social implications of the test; d. the possible significance of the results for the person concerned and for family members, and their right not to know. 2 When presymptomatic testing is conducted (Art. 3 let. e HGTA), the person concerned must additionally be informed about the conditions under which insurance providers may request the disclosure of data from genetic tests performed (Art. 43 and Art. 44 HGTA).
Art. 8a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 1 — SR 810.12
Art. 8b Information in cases of prenatal risk assessment
When a prenatal risk assessment is conducted (Art. 3 let. h HGTA), the pregnant woman must additionally be informed about the matters specified in Article 23 HGTA.
Art. 8b — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). SR 810.12
Art. 8c Form of consent
1 Consent must be signed by hand or given in electronic form. 2 The declaration of consent must: a. be dated; and b. be readable during the entire required retention period. 3 Consent given in electronic form is permissible provided that: a. it has been given using a method which unequivocally identifies the person concerned; b. the chosen method prevents an overhasty decision; c. it is protected against modification in accordance with the state of the art; d. it is described in the application documents how the requirements specified in letters a–c are met. 4 The person concerned can choose to receive a copy of the information documents and the declaration of consent either on paper or in electronic form.
Art. 8c — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 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 adults with capacity; b. provision of written information and consent would be disproportionate, given the project design; and c. reference is made to the departure from written form in the application to the responsible research ethics committee (ethics committee). 2 In individual cases, information may be provided and consent granted in a non‑written form if: a. the person concerned, for physical or cognitive reasons, cannot read or cannot write; and b. the project leader furnishes proof of the provision of information and consent, specifically by means of written confirmation by witnesses, or by a recording of verbal consent. 3 In individual cases, the requirement to provide information in written form may be waived if: a. this could only be implemented with disproportionate effort, given the languag
Art. 9a Communication of results
1 The right of the persons concerned to receive information as specified in Article 8 paragraph 1 HRA applies to results concerning their health obtained by means of tests meeting current standards of analytical and clinical validity. 2 Results must be communicated to the persons concerned or, where applicable, to their legal representative, designated trusted person or the next of kin (Art. 22–24 HRA) in cases where: a. the results are subject to a legal notification requirement which stipulates or involves informing the person concerned about the result; b. the results may entail a public health measure which stipulates or involves informing the person concerned about the result; c. the results must be noted by the person who is to be informed, in order to protect the life and health of third parties or of the person lacking capacity concerned by the test.
Art. 9a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 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 Anonymisation of the biological material and personal data may be dispensed with if: a. the person concerned expressly renounces this right when revoking consent; or b. it is established at the beginning of the research project that anonymisation is not possible and the person concerned, having been adequately informed of this fact, consented to participate. 3 Persons revoking consent must be offered any follow-up care required to protect their health.
Art. 11 Research projects in emergency situations
For research projects in emergency situations, Articles 15–17 ClinO apply mutatis mutandis.
SR 810.305
Art. 12
Repealed by No I of the O of 7 June 2024, with effect from 1 Nov. 2024 (AS 2024 321).
Art. 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 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 ClinO apply mutatis mutandis.
Para. 4 — SR 810.305
Section 2 Approval Procedure
Art. 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 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.
Art. 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 a research project as specified in Article 6 letter a, 2. the ratio between the likely risks and burdens and the expected benefits (Art. 12 para. 2 HRA), 3. the measures taken to minimise risks and burdens, and for the protection and follow-up of participants (Art. 15 HRA), including precautionary measures in the handling of personal data, 4. the need to involve persons, and in particular persons who are particularly vulnerable (Art. 11 HRA), 5. the criteria for the selection of participants, 6. the proposed procedure for providing information and obtaining consent, including the appropriateness of the period for reflection, 7. the appropriateness of the remuneration for participants and compliance with the prohibition of commercialisation (Art. 9 HRA), 8. compliance with scientific integrit
let. cbis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). let. dbis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). let. f — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321, 581).
Art. 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 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.
Art. 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 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.
Art. 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 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 modification. At the same time, the project leader shall provide information on the reasons for the modification. 3 The following are considered to be substantial modifications: a. modifications affecting the participants’ safety and health, or their rights and obligations; b. modifications to the protocol which concern the goal or the central topic of the research project; c. a change of research site or conducting the research project at an additional site; or d. a change of project leader or sponsor. 4 The ethics committee shall reach a decision on substantial modifications within 30 days. Article 16 applies mutatis
Para. 3 let. b — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 19 Procedure for accompanying examinations involving ionising radiation
1 In the case of accompanying examinations involving ionising radiation, the project leader shall additionally submit to the responsible ethics committee the documents specified in Annex 2 number 2. Subject to the provisions of paragraphs 2–6, the approval 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 if: a. a radiopharmaceutical employed is not used in accordance with the authorisation or is not authorised in Switzerland; b. a medical device employed which is capable of emitting ionising radiation: 1. is not used in accordance with the instructions for use, or 2. does not bear a conformity marking in accordance with Article 13 MedDO; or c. some other radioactive source is used. 3 If additional documentation has to be submitted in accordance with paragraph 2, the project leader shall inform the ethics committee accordingly. 4 The FOPH shall, within a reasonable period, deliver
Art. 19 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321, 581). Para. 2 let. b let. 2 — SR 812.213
Section 3 Notifications and Reporting
Art. 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 measures, and of the circumstances necessitating them, within 7 days.
Art. 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 excluded that the event is attributable to the sampling of biological material or the collection of health-related personal data, and which: a. requires inpatient treatment not envisaged in the protocol or extends a current hospital stay; b. results in permanent or significant incapacity or disability; or c. is life-threatening or results in death. 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 report a serious event to the ethics committee 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 m
Para. 3 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 5 — Repealed by No I of the O of 7 June 2024, with effect from 1 Nov. 2024 (AS 2024 321).
Art. 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.
Art. 23 Assessment, notification and reporting on the use of ionising radiation
1 In the case of research projects involving any use of ionising radiation, the project leader shall assess compliance with the dose constraint specified in Article 45 of the Radiological Protection Ordinance of 26 April 2017. 2 If the permitted dose constraint is exceeded, the project leader shall notify the competent ethics committee within seven working days of it becoming known. 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 the completion or premature termination of a research project which included accompanying examinations involving ionising radiation, 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 for the participants. 5 Radiopharmaceuticals used in accordance with the authorisation and medical
Art. 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). Art. 23 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 1 — SR 814.501 Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 4 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 5 — Amended by No I of the O of 7 June 2024, in force since 1