Guidance
Published on: March 24, 2025
Embedding Ethical Considerations Relating to Global Representation in Clinical Research offers a thorough exploration of the ethical issues surrounding global representation in clinical trials. Central to the document is the ethical imperative to ensure that clinical research reflects the populations most affected by the diseases being studied while addressing the systematic inequalities that limit access to participation. The guide raises key ethical questions: Are the right groups being included in the research? How can we ensure that participants will benefit from the outcomes, both during and after the study? How are diverse populations, particularly in low-resource settings, engaged ethically and without exploitation?
This document also provides a valuable framework for study sponsors and research teams, offering a series of ethical considerations and questions that should be addressed throughout the study process. These considerations include the need for thoughtful engagement with local communities, careful assessment of barriers to participation, and strategies to reduce the risk of exploitation or undue inducement. By documenting their responses to these ethical questions, sponsors and study teams can ensure that their studies are conducted with integrity, fairness, and respect for all participants, helping to create research that is not only scientifically valid but also ethically sound and globally representative.
Related Resources
- Global Representation webpage
- Working with Partner Countries to Strengthen Research Capacity Relating to Global Representation
- Global Representation Roadmap: Prompts for Developing a global diversity, equity, inclusion, and accessibility (DEI) strategy
- Model Diversity Action Plan (DAP)
- “Trials Beyond Borders” podcast
- First, do no harm: a global perspective on diversity and inclusion in clinical trials