New implementing regulations apply as of 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 enter into force on 1 November 2024, with the exception of the provisions on transparency, which enter into force on 1 March 2025.

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 provisional amending enactments for the following ordinances and the associated explanations can be viewed on the FOPH’s website “Legislative project: Revision ordinances” under the “Documents” tab:

• Amendment to the Clinical Trials Ordinance (ClinO)
• Amendment to the Ordinance on Clinical Trials with Medical Devices (ClinO-MD)
• Amendment to the Human Research Ordinance (HRO)
• Amendment to the HRA Organisation Ordinance (OrgO-HRA)
• Explanatory notes on the amendments to the ordinances

The final amending enactments will be published at a later date in the official compilation.

The complete texts of the revised ordinances will only be published in the Classified Compilation in a few weeks.

We will inform you here as soon as they are available.

Staggered entry into force from 1 November 2024
The new regulations enter into force on 1 November 2024. This does not include the new regulations on transparency (e.g. the obligation to publish a summary of the clinical trial results), which will not come into force until 1 March 2025. This will allow electronic systems to be adapted to the new requirements.

Transitional regulations for research projects that have already been authorised
(cf. amending enactments Art. 72 ClinO, Art. 48b ClinO-MD and Art. 49 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.

Transitional regulation on transparency for clinical trials under ClinO
(cf. Art. 72 para 1 ClinO)

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

- 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.
(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))

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

- Certain trials with medicinal product now fall into Category B instead of Category C.
(ClinO: Art. 19 (amended) and Annex 2^bis (new))

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

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.
(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))

- 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 must be observed, including when informing participating individuals.
(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))

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

- 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.
(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))

- 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.
(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)

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

How should researchers go about preparing new applications until 1 November 2024?
Researchers who are currently preparing applications for clinical trials under ClinO or ClinO-MD or research projects under the HRO can continue to use the currently valid templates and forms from swissethics and Swissmedic for the time being. For any additional information required under the future legislation, in the coming months the enforcement authorities will provide supplements to the templates that take the new requirements into account. This will ensure that the transition is as smooth as possible.