The success and impact of scientific research is greatly influenced by gender, ethics, and contextual issues. Inclusion of women and marginalized groups in the leadership of research projects, in their capacity-building activities, and as research participants reduces bias in the findings, increases trust and acceptability of research outcomes, and contributes to long-term and sustained impact. While research ethics principles are well-established and generally understood by the research community, their interpretation and application vary from context to context. For example, the process of informed consent must be different for the more literate vs less literate participants. These issues can be a source of conflict and delays in international clinical trials.

Furthermore, in north-south collaborations, there is often an imbalance. Partners from low-and middle-income countries (LMICs) are frequently relegated to the role of mere data collectors rather than being engaged as equal peers. Ideally, trials conducted in LMICs should be led by organizations in these countries. Authorship of academic articles should also reflect a balance of power. However, local researchers in LMICs often do not have the time or capacity to fully engage with the research due to heavy workloads and other contextual challenges. Therefore, we must design systems that enable effective collaboration by training and providing adequate time and resources to these partners. Intentional efforts are needed to counteract biases and imbalances.

There are also practical considerations that stem from these gender and ethical issues or from the practical realities and regulations in different countries – from shipping logistics and supply chains (as well as maintenance) to local regulatory approvals (vs FDA or CE mark), data sharing and specimen storage (biobanking). When establishing international collaborations, consideration must also be given to the availability of laboratory infrastructure for sample storage, such as biobanks. In some cases, building new infrastructure and capacity is necessary to ensure smooth operations.

Gender, inclusion, and ethics are essential pillars of Holicare, and we see the international clinical trial as an opportunity to incorporate a gender-diverse perspective. We can work towards a more inclusive and effective research environment by designing systems that promote equitable participation and ensuring that collaborations are truly peer-to-peer.