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Each session concluded with plenary discussion and was followed by intense, small group discussion.The small groups comprised geographically diverse participants so each could learn from the others’ experience and point of view.Decisions about inclusion should be based on principles of justice, the need for evidence on efficacy and balanced assessments of maternal and foetal risk.Participants agreed that as protocols are developed, consideration should be given not only to the risks of participation but also to the risks to the pregnant woman and/or fetus if she is included in the research.The GFBR holds an annual meeting centered on a key emerging theme of significance for global health research.Pregnancy is a critical focus for global health research that has not received sufficient international attention and consideration from the bioethics, clinical and policy-making communities working together.
61 participants were from LMICs The case studies contained in this Supplement Issue formed the basis of the GFBR meeting and were themed by context: pregnancy specific research, non-communicable disease, communicable disease, and public health emergencies.
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Research ethics committees (RECs) should be encouraged to consider both the risks of participation and non-participation for the woman and fetus, bearing in mind it is in the interests of a fetus to have a healthy mother.
Researchers should be required to justify why pregnant women should be excluded from research if there is a possibility that the research may benefit the pregnant woman, the fetus, or the future child individually, or may benefit pregnant women or the children they will bear as a class.Questions about the appropriateness and sensitivity of research and guidelines to the local context are often most acute for research conducted in low- and middle-income countries (LMICs) and have resulted in a long history of concerns about exploitation and unethical practice .