Supporting RECs/IRBs to review the enrolment of pregnant/lactating individuals in HIV prevention trials using international ethical guidance

There are notable data gaps for safety, dosing and effectiveness of many health products for pregnant and lactating individuals. There have been growing calls to timeously include this population in clinical trials to generate evidence-informed interventions for them and their foetus/nursing infants. This echoes calls for a better evidence base to address the HIV prevention needs of this population. Research Ethics Committees (RECs) or Institutional Review Boards (IRBs) are centrally positioned to review if enrolment of pregnant/breastfeeding individuals is ethically acceptable, according to leading ethics guidance. To perform this task, REC/IRBs may benefit from a better understanding of current recommendations from these international ethics guidelines. We aimed to identify pregnancy-related recommendations from key international ethics guidance documents, to identify areas of conflict and to support RECs/IRBs to efficiently and systematically identify whether ethics recommendations are met. We found a rich abundance of relevant ethics recommendations. We also found that most guideline recommendations are synergistic, with the most notable divergence arising in the terminology used for when it is acceptable to transition from preclinical (animal) studies to exposing pregnant/lactating humans to the study product. We developed a brief resource setting out guidance-informed queries that REC/IRB reviewers could use to focus their review. REC/IRBs are well-placed to judge the ethical acceptability of enrolling pregnant and lactating individuals in clinical trials of HIV prevention, leveraging rich, largely synergistic ethics recommendations from leading documents.