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. 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 particular: a. procuring, bringing together or collecting biological material or health‑related personal data; b. registration or cataloguing of biological material or health-related personal data; c. storage or inclusion in biobanks or databases; d. making accessible or available or transferring biological material or health‑related personal data.
Art. 25 Anonymisation
1 For the anonymisation of biological material and health-related personal data, any association with a specific person must be rendered impossible or eliminated in such a way as to allow this association to be re-established only with disproportionate effort. 2 Anonymisation must be effected using a method based on the current state of the art. In particular, items of data which, individually or in combination, allow the association with a specific person to be re-established, such as the first name, surname, address, date of birth or unique identification numbers, must be deleted or modified. 3 The method used for anonymisation must be documented, including a description of the residual risk of reidentification.
Art. 25 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 26 Coding
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, without access to the key or to the source data, it is only possible with disproportionate effort to link the biological material or the health–related data to a specific person. 2 Coding must be effected using a method based on the current state of the art. 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 or organisational unit to be designated in the application, not involved in the research project.
Art. 26 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 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 of the person concerned; b. a legal basis exists for breaking the code; or c. breaking the code is necessary to guarantee the rights of the person concerned, and in particular the right to revoke consent.
Section 2 Informed Consent and Information
Art. 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, purpose and duration of, and procedure for, the research project; b. their right to withhold or to revoke their consent at any time without giving reasons; c. the consequences of revocation of consent for the biological material and personal data used up to this point; d. their right to receive information at any time in response to further questions relating to the research project; 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. measures to protect the biological material and the personal data; g. the main sources of financing for the research project; h. other points relevant to their decision. 2 The information may be additionally presented in a non-textual form. 3 The form of consent is governed by Article 8c. 4 Article 9 applies mutatis mutandis.
Para. 3 — 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).
Art. 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 use of the coded biological material and coded genetic personal data for research purposes; b. their right to withhold or to revoke their consent at any time without giving reasons; c. measures to protect the biological material and personal data, and in particular management of the key; d. the possibility of the biological material and the genetic personal data being passed on to third parties for research purposes. 2 The form of consent is governed by Article 8c paragraphs 1, 2 letter a, 3 letters a–c and 4. 3 Article 9 applies mutatis mutandis.
Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 3 — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 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 of the biological material and genetic personal data for research purposes; b. their right to object; c. the consequences of anonymisation with regard to results concerning their health; d. the possibility of the biological material and the data being passed on to third parties for research purposes.
Art. 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 of the non-genetic health-related personal data for research purposes; b. their right to withhold or to revoke their consent at any time without giving reasons; c. their right to be informed of results concerning their health, and their right to forgo such information; d. measures to protect the personal data; e. the possibility of the personal data being passed on to third parties for research purposes. 2 The form of consent is governed by Article 8c paragraphs 1, 2 letter a, 3 letters a–c and 4. 3 Article 9 applies mutatis mutandis.
Para. 2 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 3 — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 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 use of the non-genetic health-related personal data in coded form for research purposes; b. their right to object; c. measures to protect the personal data, and in particular management of the key; d. the possibility of the personal data being passed on to third parties for research purposes.
Section 3 Approval Procedure and Notification Requ
Art. 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 to answer a scientific question.
Art. 34 Review areas
1 The responsible ethics committee shall review: a. the completeness of the application; b. the fulfilment of the conditions specified in Articles 32 and 33 HRA; bbis. the scientific quality; c. for research projects involving biological material and health-related personal data in coded form: correct and secure coding; d. compliance with the requirements for the storage of biological material or health-related personal data; e. the professional qualifications of the project leader and the other persons involved in the research project; f. other areas, where this is necessary to assess the protection of the persons concerned. 2 In this process, it shall take into account existing approvals from ethics committees with regard to the biological material or the health-related personal data.
Para. 1 — Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321). Para. 1 let. bbis — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 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: Article 17.
Art. 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 termination of the research project within 90 days.
Section 4 Approval Procedure and Notification Requ
Art. 37 Review areas
The responsible ethics committee shall review: a. the completeness of the application; b. the reasons, as specified in Article 34 letters a and b HRA; c. the interests of the intended research which outweigh the interests of the person concerned in deciding on the further use of his or her biological material and health-related personal data; d. the group of persons entitled to pass on the biological material and the personal data; e. compliance with the requirements concerning the storage of biological material or health-related personal data and the group of persons with access rights; f. the professional qualifications of the persons entitled to receive the biological material and the personal data; g. other areas, where this is necessary to assess the protection of the persons concerned.
Amended by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 321).
Art. 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 according to a standard protocol, but in different cantons: the procedure specified in Article 17.
Art. 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 biological material and health-related personal data covered by the approval; c. the group of persons entitled to pass on the biological material and the health-related personal data; d. the group of persons entitled to receive the biological material and the personal data.
Art. 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 completion or premature termination of the collection process within 90 days.