Jamieson Denise J, O'Sullivan Mary Jo, Maupin Robert, Cohen Mardge, Webber Mayris P, Nesheim Steven, Lampe Margaret, Garcia Patricia, Lindsay Michael, Bulterys Marc
Division of HIV/AIDS Prevention, NCHSTP, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop E-45, Atlanta, GA 30333, USA.
J Womens Health (Larchmt). 2003 Nov;12(9):889-95. doi: 10.1089/154099903770948113.
Although increasing attention has been focused on the adequacy of the informed consent process for participation in research studies, there has been little systematic evaluation of the process, particularly when consent is obtained in the labor and delivery setting. The Mother Infant Rapid Intervention at Delivery (MIRIAD) study is an ongoing multisite study initiated by the Centers for Disease Control and Prevention (CDC) designed to evaluate the feasibility of offering 24-hour counseling and voluntary rapid HIV testing and antriretroviral therapy when indicated to women with unknown HIV status who are in labor.
To address concerns about obtaining informed consent from women in labor, we have completed focus groups, conducted a pilot of the informed consent process among women in labor, developed flip-charts to enhance comprehension, and plan an ongoing evaluation of the informed consent process throughout the course of the MIRIAD study.
In the pilot study, approximately 70% of women were able to state in their own words the purpose and benefits of the research study. Substantially fewer women (25%) were able to state one or more risks of the study.
We hope that the MIRIAD study will make a valuable contribution by defining best approaches for informed consent and will provide guidance when it is necessary to obtain consent from laboring women for crucial interventions.
尽管越来越多的注意力集中在参与研究的知情同意过程的充分性上，但对该过程的系统评估却很少，尤其是在分娩环境中获得同意时。分娩时母婴快速干预（MIRIAD）研究是美国疾病控制与预防中心（CDC）发起的一项正在进行的多地点研究，旨在评估向分娩时HIV感染状况不明的妇女提供24小时咨询、自愿快速HIV检测及必要时的抗逆转录病毒治疗的可行性。
为解决在分娩妇女中获取知情同意的相关问题，我们完成了焦点小组讨论，在分娩妇女中开展了知情同意过程的试点，制作了大幅图表以增强理解，并计划在MIRIAD研究过程中对知情同意过程进行持续评估。
在试点研究中，约70%的妇女能够用自己的语言陈述研究的目的和益处。能够说出研究的一种或多种风险的妇女则少得多（25%）。
我们希望MIRIAD研究将通过确定知情同意的最佳方法做出宝贵贡献，并在需要为关键干预措施从分娩妇女处获得同意时提供指导。
