Table 4.

Overall insights into regulatory and ethical challenges for BDS.

Categories	Insights
Regulatory Challenges	Biological variability and complexity Achieving consistent reproducibility Potential unprecedented interactions with biological entities
Regulatory Frameworks	Adaptive oversight mechanisms Interdisciplinary dialogues Harmonized global standards
Ethical Challenges	Sourcing material from sentient entities (humans/animals) Informed consent and potential exploitation Equitable accessibility in diverse settings
Ethical Frameworks	Broadened boundaries of informed consent Stakeholder participation Pursuit of transparency