Ethics Compliance in the Synapsing Project: Privanova Leading the Way

Synapsing Ethics Evaluation

Synapsing is committed to reducing the health burden of untreated psychiatric symptoms in mental disorders (e.g. depression and schizophrenia) and neurodegenerative diseases (e.g. Alzheimer's disease). The difficulty in addressing these conditions lies in the fact that the most commonly used treatments, such as antidepressants and antipsychotics, frequently prove to be ineffective, resulting in a significant burden for patients, their families, and society overall.

Synapsing aims to create a database of clinical, neuroimaging, and socioeconomic data from over 3000 patients, providing insights into the shared mechanisms behind these conditions to improve diagnosis and treatment strategies.

However, dealing with such sensitive and important issues inevitably brings to light various ethical concerns. The Synapsing project received a Conditional Ethics Clearance outlined in the Ethics Summary Report, providing essential guidelines for addressing the project's ethical challenges.

Synapsing Ethics Compliance Challenges

The primary ethical requirement concerns ethical handling, involvement, and procedures related to the human factor, which includes patients and volunteers. In this regard, Synapsing is required to minimise the risk of exploitation, stigmatisation, and discrimination for the vulnerable population involved throughout the project, taking into account the possibility that their cognitive capacities degenerate over time.

Another ethical requirement concerns sourcing the human cells/tissues, which requires appropriate sourcing. An important factor of ethical research in any R&I project is related to practices of handling personal data. Synapsing has to ensure data protection, for example:

• personal data collected during the clinical studies is processed in line with GDPR,
• data will be anonymised/pseudonymised to ensure long-term privacy protection, especially for sensitive medical data.

Synapsing Ethics Compliance: roles & responsibilities

Privanova's Ethics Advisory services are designed to ensure that your EU project adheres to the highest ethical standards within the EU Ethics Appraisal Scheme. We provide a structured approach to identifying, assessing, and mitigating ethical risks throughout the project lifecycle. By integrating ethics into the core of project planning and execution, these services help projects not only comply with legal requirements but also align with societal values and expectations.

In response to the EC Ethics Evaluation Report, Privanova converted the Ethics requirements into practical steps for the Synapsing consortium partners to comprehend, enact, and adhere to throughout the project's entire duration. All consortium partners commit to cultivating a responsible research and innovation mindset while creating and developing the project's results.

As one of the key ethics-ensuring activities, Privanova established an Ethics Advisory Board to act as an independent board of ethics experts, carefully tracking project activities, overseeing and advising on ethics issues.

The Ethics Advisory Board includes external experts in the EU Ethics Appraisal Scheme, Privacy and Data Protection, and relevant areas for Synapsing's research activities. The independent board members will be asked to assess the deliverables at each reporting period and to share their perspectives on ethical and social matters related to the project, as well as to suggest possible solutions. Here you can find the Ethics Appraisal Process: Main Reference Documents.

Synapsing Ethics Compliance Monitoring

Monitoring ethics compliance in Horizon Europe projects requires a systematic approach that integrates ethics into every stage of project implementation, particularly during events such as workshops, surveys, pilot demonstrations, and dissemination activities.

When organising project events, with workshops or surveys, the consortium must prioritise adherence to EU data protection regulations (e.g., GDPR). This involves safeguarding personal data collected during these activities by anonymising it wherever possible and obtaining explicit consent for its use. Proper documentation of these processes—such as informed consent forms and ethics approvals—is essential to demonstrate compliance. These documents must be securely stored and readily accessible for audits or reviews.

Dissemination activities, including newsletters, social media campaigns, and publications, must align with ethical standards. For dissemination purposes, the project should aim for transparency while ensuring that personal data is not disclosed without explicit consent. Additionally, anonymised data should be used whenever feasible to protect privacy. Dissemination materials should provide accurate information and avoid any misleading content.

Regular ethics audits should be conducted to ensure continuous compliance with ethical standards and to identify areas that need improvement. These audits are essential for maintaining ethical practices throughout the project lifecycle. Synapsing utilises the established Ethics Advisory Board for auditing, providing expertise and guidance.

By integrating ethics into project planning from the outset—through self-assessments, obtaining necessary approvals, and cooperating with experts—the consortium can ensure adherence to the highest ethical standards. Following these practices not only fulfills Horizon Europe's requirements but also reinforces respect for fundamental EU values such as human dignity, democracy, equality, and human rights.

This interconnected approach ensures that Synapsing meets ethical obligations effectively while minimising risks to participants and stakeholders.