The In Silico World consortium released the “Legal and Ethical Inventory” document, which is part of the ‘Ethical and Legal Framework’, and provides an overview of the core pieces of legislation and ethical principles that are relevant to the In Silico project, and thus, in silico trials.
- Privacy and Data Protection: The data processed for in silico trials entail the processing of personal data of individuals (notably, patients) in healthcare settings.
- Data Governance: In healthcare and in silico trials, the sharing of data across healthcare facilities may be considered a key factor for the development, testing, and validation of in silico models.
- Clinical Trials: The legislation and regulatory documentation concerning clinical trials are relevant to the very essence of in silico trials.
- Medical Devices and Medicinal Products: From a product regulation perspective, in silico trials encompass medical devices and medicinal products.
- Artificial Intelligence (AI): It is no surprise that a fundamental component of in silico trials is artificial intelligence. The EU legal framework on Artificial Intelligence is in the process of being established.
In addition to the above pieces of legislation, the study outlines the framework for forthcoming Ethics guidelines. Based on a principlist approach, these guidelines propose the analysis of four main Biomedical Ethics principles – i.e. autonomy, justice, beneficence, non-maleficence – and the secondary principle of responsibility. These principles will ultimately be beneficial for studying the fundamental ethical principles that may be used as guidance for interpreting the law and supporting stakeholders to ensure the protection and advancement of human values in the context of in silico trials.
This work provides a descriptive overview of the above-mentioned legal frameworks. It is prodromic to the next phases of the “Legal and ethical framework”, where the analysis will adopt an evaluative approach on legislation to ultimately result in policy recommendations.
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