Rethinking global clinical trial standards: UCL GBSH research highlights ethical and cultural gaps

The UCL Global Business School for Health is pleased to share new research published in the Journal of Medical Ethics examining the global relevance of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines.

International clinical trial standards play a critical role in protecting participants and ensuring scientific quality. However, as more clinical research is conducted across diverse global settings, particularly in low- and middle-income countries (LMICs), concerns are growing about whether these guidelines sufficiently account for cultural, social and ethical differences.

Led by Dr Hend Abdelhakim, Assistant Professor at UCL GBSH, alongside an international group of collaborators, the paper explores how aspects of the ICH GCP framework may be ill-suited to contexts where norms around decision-making, governance and community engagement differ from those assumed in high-income settings.

Drawing on global perspectives, the authors identify key challenges related to informed consent, ethical oversight and meaningful community engagement. For example, standard consent processes often prioritise individual autonomy, while in many settings decision-making is collective, involving families or community leaders. Differences in literacy levels, trust in institutions and social norms can also affect how research is understood and experienced by participants.

Rather than rejecting international standards, the paper argues for more inclusive and context-sensitive approaches to clinical research governance. The authors call for greater flexibility within global guidelines and stronger involvement of local stakeholders to ensure ethical protections remain effective without excluding or marginalising communities.

This research reflects UCL GBSH’s commitment to ethical leadership, equitable healthcare innovation and responsible global research practice — values that underpin its teaching, research and international partnerships.

Read the open-access article here.