New implementing regulations in force since 1 November 2024

The Federal Council approved the amendments to the ordinances relating to the Human Research Act (HRA) and adopted them on 7 June 2024. The amendments strengthen the protection of persons participating in research and, where possible, improve the regulatory framework for researchers. The amended ordinances entered into force on 1 November 2024, with the exception of the provisions on transparency, which enter into force on 1 March 2025.

*Update of November 1, 2024

The amended ordinances came into force on 1 November 2024

The four amended ordinances to the Human Research Act came into force on 1 November 2024.

This does not include the new provisions on transparency (e.g., the obligation to publish a summary of clinical trial results), which will not come into force until 1 March 2025. The provisions in question are the amended Section 5 of the ClinO (Art. 64–67) and the amended Section 5 of the ClinO-MD (Art. 41 and 42). This will allow electronic systems to be adapted to the new requirements.

Slideset on the revision of the ordinance for enforcement authorities and researchers

The FOPH, in collaboration with swissethics and Swissmedic, has created a slideset with information on the revision of the ordinance for enforcement authorities and researchers. This is available in the ‘Downloads’ section or directly below (link) and can be used for training as well as for general information purposes.

Slideset FOPH, Swissmedic and Swissethics on the revision of the ordinance, as of 1 November 2024

*Update of September 17, 2024

How should researchers go about preparing new applications until 1 November 2024?

The enforcement authorities published information for applicants on September 16, 2024, regarding the practical procedure during the transition to the revised ordinances.

Updated instructions and templates are available on the websites of swissethics and Swissmedic.

*Publication as per June 7, 2024

Adapting human research legislation in response to technological and social changes

The amendments to the four ordinances accompanying the HRA adopted on 7 June 2024 introduce a number of improvements and adapt the provisions to technological, scientific and societal changes and international developments.

Amended ordinances

The four ordinances accompanying the Human Research Act were amended as part of the partial revision. 

The new regulations enter into force on 1 November 2024.

This does not include the new provisions on transparency (e.g. the obligation to publish a summary of clinical trial results), which will not come into force until 1 March 2025. The provisions in question are the amended Section 5 of the ClinO (Art. 64–67) and the amended Section 5 of the ClinO-MD (Art. 41 and 42). This will allow electronic systems to be adapted to the new requirements.

The amended ordinances in the version dated 1 November 2024, together with the Explanatory Report, have been published in the Classified Compilation (SR) and can be viewed via the following links (currently only available in French, German and Italian):

*N.B. The provisions which will not come into force until 1 March 2025 (i.e. the amendments in Section 5 of the ClinO and of the ClinO-MD; see above) are not shown in the versions dated 1 November 2024. They will appear in the versions dated 1 March 2025. 

The versions of the ClinO and of the ClinO-MD dated 1 March 2025 can be found here:

Clinical Trials Ordinance (ClinO) in the version dated 1 March 2025 – coming into force on 1 March 2025

Ordinance on Clinical Trials with Medical Devices (ClinO-MD) in the version dated 1 March 2025 – coming into force on 1 March 2025

 

Transitional regulations for research projects that have already been authorised

(cf. amending enactments Art. 72 ClinO, Art. 48b ClinO-MD and Art. 48a HRO)

The following transitional regulations apply to clinical trials and research projects that were approved under current law or that will be approved before 1 November 2024:

  • The liability, liability coverage and retention duties for research projects under ClinO, ClinO-MD and HRO will continue to be governed, even after 1 November 2024, by the law currently in force.
  • The new notification, reporting and documentation duties for ongoing clinical trials under ClinO will apply from 1 November 2024 in principle. However, until 31 October 2025 researchers are allowed to fulfil these obligations under current law.
  • The two-year period until the application must be submitted to the second authorising authority and the two-year period until the first participating person must be included into clinical trials according to the ClinO will only start to run from 1 November 2024.
  • The new rules for the categorisation of a clinical trial with medicinal products can also be applied to trials that were approved under current law. Researchers have until 31 October 2025 to apply for an adjustment of the category in accordance with the new law if they so wish. 

 

Publication of the summary of results of clinical trials under ClinO

(cf. Art. 65a ClinO)

  • As mentioned above, the amended provisions on transparency will not come into force until 1 March 2025. The duty to publish the summary of results within one year of completing a clinical trial under ClinO applies from 1 March 2025 for all trials that are completed after 1 March 2025. It does not apply to trials that are completed before 1 March 2025.  

 

Further information on the new requirements and the transitional regulations will be worked out with the enforcement authorities and published here and on the Swissmedic and swissethics websites in due course.

 

 

What are the most important changes for researchers? 

Promoting a favourable framework for research

  • Technical developments in the field of digitalisation are better taken into account: researchers can now obtain consent from research participants electronically (so-called e-consent).

 

 

 

 

  • The requirements for the correct anonymisation and coding of health-related personal data and biological material will be adapted to technical developments in the field of data processing to allow a better assessment of the risks. To ensure quality in this area, enforcement authorities and researchers must now assure certain knowledge.

 

 

 

 

  • To facilitate transnational research projects, ClinO will be amended in line with Regulation (EU) No. 536/2014 on clinical trials on medicinal products for human use (CTR). In particular, this affects the rules on notifications, reporting and deadlines for clinical trials with medicinal products. These also apply to clinical trials according to chapter 4 ClinO ("Other clinical trials") and clinical trials of transplantation.

 

 

 

 

  • Certain trials with medicinal product now fall into Category B instead of Category C.

 

 

 

  • With the newly introduced definition of the completion of a research project and a new provision on the obligation to retain data, the HRO clarifies open questions regarding the retention period of data in research projects involving human subjects.

 

 

 

Further improving the protection of individuals participating in research

  • The information provided to study participants will be further improved. Researchers must fulfil specific requirements that help provide participants with comprehensible information. In addition, when providing information, they must place particular emphasis on the possibility of incidental findings.

 

 

 

  • If prenatal or pre-symptomatic genetic tests or genetic tests for family planning are carried out, selected provisions of the Federal Act on Human Genetic Testing (HGTA) must be observed, including when informing participating individuals.

 

 

 

  • Specific requirements for the communication of individual results concretise and thus strengthen the right to information of participating individuals or the right to waive information. 

 

 

 

  • Researchers are explicitly required to include in their research project those groups of people who are relevant to the scientific objective. This refers in particular to sex and age groups.

 

 

 

 

  • The requirements for transparency in clinical trials will be harmonised with international regulations. Researchers must now publish a summary of the results. In addition, all published information must be made available in the national languages relevant to the trial.

 

 

 

 

  • For clinical trials under ClinO, the retention obligation will be extended to 20 years (with the exception of clinical trials with transplant products and clinical trials with blood and blood products, cf. Art. 45 para. 3 ClinO and Art. 40 para. 1 TPA).

 

 

 

Further information

 

  • swissethics: News

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Relevant articles in the amending enactments

ClinO: Art. 7c (new), also applicable in the ClinO-MD via art. 3 para. 1 let. b (amended); HRO: Art. 8c (new)

 

 

 

HRO: Art. 25 and 26 (amended); ClinO: Art. 6 para. 1 let. c (new); ClinO-MD: Art. 5 para. 1 let. d (new); HRO: Art. 4 para. 1 let. d (new); OrgO-HRA: Art. 1 para. 1 let. a no. 9 (new)

 

 

ClinO: Art. 23 para. 1bis – 1quater (new), 23a (new), 38 – 41 (amended), 44a (new); ClinO: Art. 50 para. 1bis – 1quater (new), 51 and 57 (amended), 57a and 57b (new), 62 (amended)

 

 

 

ClinO: Art. 19 (amended) and Annex 2bis (new)

 

 

HRO: Art. 6a and 23a (new)

 

 

 

 

 

ClinO: Art. 7 para. 1 and 4 (amended), also applicable in the ClinO-MD via art. 3 para. 1 let. b (amended); HRO: Art. 8 para. 1 (new) and para 4 (amended)

 

 

ClinO: Art. 7a and 7b (new), also applicable in the ClinO-MD via art. 3 para. 1 let.b (amended); HRO: Art. 8a and 8b (new)

 

 

ClinO: Art. 8a, also applicable in the ClinO-MD via art. 3 para. 1 let. b (amended); HRO: Art. 9a (new)

 

 

ClinO: Art. 4a, also applicable in the ClinO-MD via art. 3 para. 1 let. a (amended) and the HRO via art. 2 Bst. c (new)

 

 

 

ClinO: Art. 64 (amended) and 65a (new), Annex 5 (amended); ClinO-MD: Art. 41 and 42 (amended), Appendix 5 ClinO (amended) also applicable in ClinO-MD

 

 

ClinO: Art. 45 para. 1 and 2 (amended)