Ethical issues related to consent for intrapartum trials

Abstract

Informed consent is the heart of ethical research. For any consent to be ethically valid, it should meet certain critical criteria - disclosure and understanding of relevant information, decision making competency of the participants, voluntariness of the decision and documentation of the agreement. Meeting all these criteria to obtain ethically valid consent from laboring women while conducting intrapartum trials is challenging because there is little time available during labor to provide study specific information necessary for the participant to understand and decide to sign the consent form. Moreover, women during labor may be anxious and distressed due to labor pains which is thought to interfere with the capacity to make decisions in some cases. Emphasis on these concerns may ultimately lead to the exclusion of many eligible women in labor from intrapartum clinical trials. In this paper, we discuss the ethical challenges and also the proposed recommendations to obtain ethically valid consent from women for conducting intrapartum clinical trials.