NAMs HREC Review Checklist

Bellberry and ASCEPT, the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists, are pleased to release the draft NAMs HREC Review Checklist for consultation.

Meeting 1 November 2024 Melbourne

The aim:

To understand what’s required to enable the responsible, ethical use of NAMs in the transition from preclinical research to clinical trials. Perspectives from

• Regulator
• HREC leaders
• Technology developers
• Sponsors
• Researchers

Meeting 2 October 2025 Melbourne

Aims:

• Explore regulatory expectations and acceptance of data from NAMs
• Provide hands-on understanding of applications using NAMs to support FIH trials
• Identify practical barriers and strategies to implement NAMs through case studies and group discussions
• Empower participants to evaluate data from NAMs critically and navigate uncertainties

Meeting 3 July 2026 Melbourne

Launch of practical guidance for ethics review and decision-making using NAM guidance and Delphi methodology. Draft checklist open for consultation until 5 October 2026.