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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