What is Fair Representation in Research?

Friesen et al. (Citation2023) article explores tensions within institutional review boards (IRBs) when they aim both to protect participants from harm and to include under-represented populations in clinical research, in what they call a protection-inclusion dilemma. Their analysis is timely and important, given recent policy efforts to improve clinical trial diversity and studies showing a need for reform. In this comment, we explore three additional considerations in advancing fair inclusion of demographic groups in clinical research. First, we ask what in fact should constitute ideal or even adequate diversity and fair inclusion in research–an under-addressed question. Second, we highlight potential tensions between striving to represent US-patients in trials and global health needs. Third, we discuss data limitations in need of attention if IRBs, sponsors, researchers among other stakeholders are to aim for and evaluate the adequacy of diversity and fair inclusion in research.