Ethical Compliance – KoySLab – Knowledge for Simplification

Guiding Innovation with Integrity and EU Alignment

Ethical Compliance is a specialised service that helps organisations embed ethics into their innovation processes while ensuring full alignment with EU laws, international agreements, and societal values. In today’s regulatory and geopolitical context, innovation must not only be effective and competitive—it must also be responsible, inclusive, sustainable, and ethically sound.

What We Offer – Key Areas of Ethical Compliance

Responsible Research and Innovation (RRI): We help operationalise the EU’s RRI agenda—embedding ethics, gender balance, open access, and stakeholder engagement throughout your innovation lifecycle, as emphasised in Horizon Europe and ERA policies.
Equity and Inclusivity: We support alignment with the European Pillar of Social Rights, ensuring innovations benefit all communities, including marginalised and vulnerable groups.
Privacy and Data Protection: We guarantee Compliance with the General Data Protection Regulation (GDPR – Regulation (EU) 2016/679), offering best-in-class solutions for ethical data use, storage, and sharing.
Transparency and Accountability: Following the AI Act, Digital Services Act (DSA), and Data Governance Act, we support the implementation of explainable and traceable technologies to build user trust.
Informed Consent: We ensure that research and technological interventions respect autonomy and integrity through ethically sound consent protocols, which are especially important in health, genomics, and AI applications.
Risk Assessment and Management: Our methods align with AI Act risk categories, Medical Device Regulation, and REACH/CLP guidelines, helping organisations foresee and mitigate societal and environmental risks.
Sustainability: We assess innovation impacts through the lens of the European Green Deal, EU Taxonomy Regulation, and Corporate Sustainability Reporting Directive (CSRD) to ensure environmental and intergenerational responsibility.
Bias and Discrimination Prevention: We detect algorithmic and structural biases, aligning with the Charter of Fundamental Rights of the EU and the ethical guidelines for Trustworthy AI.
Dual Use and Security Concerns: We evaluate Compliance with the EU Dual-Use Regulation (Regulation (EU) 2021/821), ensuring that sensitive or potentially dangerous technologies are used responsibly.
Intellectual Property and Open Access: Our team helps balance innovation protection with public benefit under EU Open Science policies and the Copyright Directive (EU 2019/790).
Democratic Governance and Public Engagement: We facilitate inclusive stakeholder processes in line with EU RRI principles, the European Democracy Action Plan, and participatory ethics.
Techno-solutionism Awareness: We promote critical reflection on over-reliance on technological fixes, encouraging holistic, multidisciplinary innovation approaches.
Intergenerational Justice: We help assess long-term implications, ensuring innovations respect future generations and are aligned with the Just Transition Mechanism and EU sustainability commitments.

Bioethics and Biodiversity – Our Commitment to Ethical Biological Innovation

We recognise that biological and ecological innovations raise unique ethical and legal concerns. That is why Ethical Compliance integrates bioethical and biodiversity-related frameworks, such as:

Nagoya Protocol on Access and Benefit-Sharing (ABS): We ensure Compliance with this international agreement and its implementation in the EU Regulation (Regulation (EU) No 511/2014), governing access to genetic resources and the fair sharing of benefits arising from their use.
Convention on Biological Diversity (CBD): We support ethical and legal practices in the use of biological resources, especially in R&D, biotechnology, pharmaceuticals, agriculture, and bioprospecting.
Human Biological Materials: In health and biomedicine, we provide guidance on the ethical use of human samples and genomic data in line with the EU Clinical Trials Regulation (CTR 536/2014) and the Council of Europe’s Oviedo Convention.
Animal Welfare and Research Ethics: We guide Compliance with the EU Directive 2010/63/EU on the protection of animals used for scientific purposes, promoting ethical alternatives and the 3Rs (Replacement, Reduction, Refinement).
Biosecurity and Synthetic Biology: We provide ethical risk assessments and oversight models for emerging biotechnologies in accordance with EU recommendations and UNESCO bioethics declarations.