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Table 1 Key ELSI

From: Overcoming barriers to facilitate the regulation of multi-centre regenerative medicine clinical trials

Basic research Clinical research Clinical context
• Quality and integrity of research
• Transparency and publication of results
• Inherent tension between clinical progress, scientific caution and compliance with regulatory requirements
• Safety and efficacy of intervention (evidence-based)
• Informed consent
• Prohibitively high development costs
• Time- and labour-intensive
• Justice and affordability
• Pressure to commercialize
• Unproven therapies
• Right to try
• Accuracy in advertising
• Legitimacy of the informed consent obtained
• Vulnerable population exposed to unjustifiable risks