Switzerland has taken a significant step forward in regulating human research with the revision of the Human Research Act (HRA) ordinances. Approved by the Federal Council, the updated ordinances, designed to reflect advancements in digitalization, national and international standards, and research practices, officially came into effect on 1 November 2024. However, provisions on transparency will follow, coming into force on 1 March 2025.
Why the Revision?
The need for this revision emerged from a Federal Council mandate in 2019 tasking the Federal Department of Home Affairs (FDHA) with revisiting the implementing provisions of the HRA. The goal? To enhance the conditions and transparency of human research, align responsibilities between federal and cantonal authorities, and adapt to the digital transformation reshaping the research sector.
Key Highlights
- Improved Transparency: The amendments aim to make human research more accessible and accountable through updated transparency provisions.
- Digital Integration: Modernizing the research process by accounting for advancements in digital technologies.
- Streamlined Responsibilities: Adjusting the division of tasks between federal and cantonal authorities to better reflect practical needs.
Which Ordinances are affected?
The changes apply across all ordinances under the HRA umbrella, including:
- Ordinance on Clinical Trials (ClinO)
- Human Research Ordinance (HRO)
- Organisational Ordinance HRA (OrgO-HRA)
- Ordinance on Clinical Trials with Medical Devices (ClinO-MD)
- Stem Cell Research Ordinance (SCRO)
Consultation and Approval
From 26 April to 16 August 2023, a public consultation was held, inviting feedback from cantons, political parties, and other stakeholders. Based on these insights, the Federal Council finalized the amendments on 7 June 2024.
Summary Consultation Report June 2024
The consultation report regarding partial revisions to Swiss legislation on human research. Key highlights include:
- Objective of the Revisions:
- Addressing inefficiencies in human research regulation.
- Incorporating digitalization and enhancing data protection/security.
- Aligning with EU legislation (e.g., EU Clinical Trials Regulation 536/2014).
- Strengthening participant rights, including informed consent and the return of study results.
- Major Areas of Impact:
- Adjustments to responsibilities between federal and cantonal bodies.
- Promotion of gender and age inclusivity in research participation.
- Improvements in transparency, including public registries for clinical trials and results.
- Introduction of e-consent for research participants.
- Feedback from Stakeholders:
- Overall support for the proposed revisions, particularly from academic institutions and patient organizations.
- Concerns raised about the practicality of certain provisions, such as dynamic consent and transparency measures.
- Calls for stronger alignment with international best practices and additional clarity on sustainability measures in research.
- Specific Proposals:
- New Articles: Suggestions to include sustainability and environmental considerations in clinical trials.
- Diversity in Research: Advocating for the inclusion of underrepresented groups beyond gender, such as ethnic, socio-economic, and age groups.
- Ethics Committees: Calls for enhanced harmonization across cantonal ethics committees and potentially transitioning responsibilities to centralized bodies like Swissethics.
- Administrative Considerations:
- Concerns about increased administrative burden for researchers and ethics committees.
- Recommendations for transition periods and clarity on applying new rules to ongoing studies.
Concerns about increased administrative burden for researchers and ethics committees
The consultation report highlights several concerns regarding the potential increase in administrative burdens for researchers and ethics committees due to the proposed revisions to human research legislation. Here are the main points of concern:
1. Dynamic Consent Requirements
- Description: The revisions propose implementing a dynamic consent model, where participants would need to re-consent periodically or for specific additional uses of their data or samples.
- Concerns:
- Complexity for Researchers: Managing multiple rounds of consent, especially in long-term studies, would require new systems and workflows.
- Ethics Committees: These committees would need to evaluate ongoing updates to consent forms and processes, increasing their workload.
2. Transparency Measures
- Description: Enhanced transparency, such as mandatory reporting of clinical trial results in layperson-accessible language and public registries, is emphasized.
- Concerns:
- Researchers and sponsors may need to allocate additional resources for preparing and submitting lay summaries.
- Ethics committees may face challenges ensuring these reports meet the required standards of clarity and accessibility.
3. E-Consent Implementation
- Description: Transitioning to electronic consent systems (e-consent) to streamline participant interactions and align with digitalization trends.
- Concerns:
- Researchers may need to adopt or develop compliant digital tools, adding to costs and technical complexity.
- Ethics committees would need training and resources to evaluate these new digital consent tools for compliance and user-friendliness.
4. Harmonization of Regulations
- Description: Aligning Swiss regulations with EU standards and ensuring uniform practices across cantonal ethics committees.
- Concerns:
- This could lead to duplication of work during the transition period, with ethics committees needing to process additional documentation for ongoing studies.
- Researchers may face delays and increased documentation requirements to meet both existing and revised standards.
5. Increased Reporting Obligations
- Description: The revisions introduce stricter reporting obligations, including regular updates on safety, progress, and participant data.
- Concerns:
- Researchers must allocate more time and resources to meet these reporting requirements.
- Ethics committees would be responsible for reviewing a greater volume of submissions and amendments, potentially leading to bottlenecks.
6. Inclusivity Measures
- Description: The revisions emphasize diversity in participant inclusion, such as gender balance, age distribution, and representation of underrepresented groups.
- Concerns:
- Researchers would need to provide detailed justifications and protocols to ensure inclusivity, adding to their preparation time.
- Ethics committees might face challenges in assessing whether these criteria have been appropriately addressed.
7. Compliance with Sustainability Goals
- Description: New articles suggest integrating sustainability principles into research design and execution.
- Concerns:
- Researchers must incorporate sustainability analyses into study planning and report on environmental impacts.
- Ethics committees might lack the expertise or capacity to evaluate sustainability metrics effectively.
Recommendations to Mitigate Burden
- Centralized Support: Establishing national platforms or support systems (e.g., through Swissethics) to assist researchers and committees in managing new requirements.
- Standardized Tools: Creating standardized e-consent templates and reporting frameworks to reduce variability and complexity.
- Transition Periods: Implementing gradual adoption of new measures to allow stakeholders to adjust.
- Training Programs: Offering training for researchers and ethics committees on new tools, processes, and compliance standards.
- Resource Allocation: Ensuring ethics committees are adequately staffed and funded to handle the increased workload.
These measures could help alleviate the administrative challenges associated with the revisions while maintaining the high standards of ethical and scientific rigor.
New Key Challenges for MR Scientists in Light of the Revisions
In the whole report on the consultation the word “MRI” appears just one single time on page 11:
Die CTU Bern führt aus, dass mit der Erweiterung der Definition der Intervention nun weitere Forschungsprojekte unter die KlinV fallen, die bisher unter der HFV reguliert waren. Ein Beispiel seien Forschungsprojekte im Bereich der Neurowissenschaften mit Einsatz von MRI, bei welchen Effekten auf den Körper nicht zu klinischen Zwecken, sondern zum Zweck der Grundlagenforschung ausgelöst würden. Für diese Projekte seien die Anforderungen der HFV genügend, da andernfalls zusätzliche Hürden für die Forschung anfallen würden.
Conclusion Revision for MR-science
This one and only text unfortunately does not address the already existing burdens for competitive MR-research in Switzerland, but addresses a new burden of the new ClinO-MD. More specifically, I fear much more deteriorations for MR-scientists in their forced double role of sponsor and investigator:
- Increased Administrative Responsibilities as Sponsors:
- The dual role of MR scientists as both researchers and sponsors inherently adds layers of responsibility, especially regarding compliance, participant safety, and reporting.
- The burden of acting as a sponsor includes managing legal, ethical, and procedural oversight, which can detract from time spent on actual scientific inquiry.
- Transparency Obligations:
- New rules on public reporting of trial results and the requirement to make findings accessible in lay terms add to the workload. While these measures aim to enhance public trust, they demand additional resources (e.g., time, personnel, or external contractors).
- Inclusivity Measures:
- Requirements for gender, age, and demographic inclusivity in research participants might force MR scientists to invest more effort into participant recruitment strategies, especially for studies with niche or highly specific subject populations.
- Digital and Data Compliance:
- Implementing and maintaining e-consent systems and adhering to stringent data protection standards (e.g., GDPR-aligned rules) may require significant investments in infrastructure and training.
- Ensuring compliance with these digital systems can shift focus away from experimental innovation.
- Ethics Committee Reviews:
- Enhanced scrutiny from ethics committees, now with expanded responsibilities, could slow down study approvals, especially for investigational protocols like new MR pulse sequences or ultra-high-field imaging setups.
- Sustainability Mandates:
- While sustainability is a global priority, requirements to demonstrate environmental responsibility in research could impose additional reporting duties, especially for energy-intensive MR experiments.
Looking Ahead
While these revisions are a milestone, the Federal Council has further instructed the FDHA to draft a comprehensive revision of the HRA by the end of 2026, ensuring Switzerland legislation remains in sync with practices in international context.
Personal conclusion
Based on the information I have today I personally see no indication that the situation for MR-scientists in Switzerland will improve in next few years to come, on the contrary. This is extremely bad news for our important branch of science in Switzerland which resulted in three Swiss nobel prizes in the past.
The only choice left for us Swiss MR scientists is to grit our teeth, accept the bitter pill, and navigate the cumbersome legislation as best we can. This blog aims to support our community of MR scientists by providing guidance, insights, and practical tips to help us adapt and thrive despite these challenges.
When the wind of power blows the reed must bend.
Learn More
Explore the updated ordinances on the Fedlex publication platform and find additional information on their implementation via the Kofam website.
This update underscores Switzerland’s commitment to balancing innovation with ethical rigor in human research. Stay tuned as the next phase of HRA developments unfolds!