Verheggen F W, van Wijmen F C
University Hospital Maastricht, The Netherlands.
Health Policy. 1996 May;36(2):131-53. doi: 10.1016/0168-8510(95)00805-5.
A review is provided in this paper on the empirical literature on informed consent from 1979 to 1995 referring to information disclosure and trial participation in clinical trials. Articles being reviewed focus upon information disclosure, reactions to disclosure and recall, features of consent and perceptions of informed consent, both in hypothetical and in real life situations. It is concluded that further research is needed to study the process of informed consent in clinical trials, to obtain a better insight into the myth and reality of informed consent in daily practice. Future studies should come forward on the limitations of previous empirical research on informed consent. Additional research should focus on the perspectives of patients who accept or decline trial participation.
本文对1979年至1995年间关于临床试验中信息披露和试验参与的知情同意实证文献进行了综述。所综述的文章聚焦于信息披露、对披露的反应和回忆、同意的特征以及在假设和现实生活情境中对知情同意的认知。得出的结论是，需要进一步研究临床试验中的知情同意过程，以便更好地洞察日常实践中知情同意的虚构与现实。未来的研究应探讨先前知情同意实证研究的局限性。额外的研究应关注接受或拒绝参与试验的患者的观点。
