Reviewer's Report Issues of Informed Consent for Intrapartum Trials: a Proposed Consent Pathway from the Title: Experience of the Release Trial (isrctn13204258)

The authors argue that there has been little specific attention to the ethical issues that arise in conducting research with labouring women. This is not strictly true; there is a relevant literature in the area, particularly from North America. In the US, federal regulation and NIH policy require that women, including women of childbearing potential, be included in NIH research unless there is a compelling rationale that inclusion would harm the subjects or the purpose of the research. A body of research and ethical debate has grown up around the specific issues of pregnant women and of emergency situations. I would suggest that the authors have a look at Mastroianni AC, Faden R, Federman D (eds) Women and health research. Institute of Medicine, 1994.