Fitzgerald Daniel W, Marotte Cécile, Verdier Rose Irene, Johnson Warren D, Pape Jean William
Groupe Haitien d'Etude du Sarcome de Kaposi et des Infections Opportunistes, Port au Prince, Haiti.
Lancet. 2002 Oct 26;360(9342):1301-2. doi: 10.1016/S0140-6736(02)11338-9.
Few practical guidelines exist on how to ensure that research participants in less-developed countries understand the consent form before enrollment. In a study of HIV-1 transmission in Haiti, participants were required to pass an oral examination on the contents of the consent form with a passing score of 12/15 (80%) before enrollment. 15 individuals were given information during a single meeting with a physician, and three (20%) passed. 30 subsequent volunteers were given information by a counsellor during three meetings, and 24 (80%) passed. Formal assessment of research participants' comprehension of the consent form should be considered as a routine step in the informed consent process in less-developed countries.
关于如何确保欠发达国家的研究参与者在入组前理解知情同意书，几乎没有实用的指导方针。在海地一项关于HIV-1传播的研究中，要求参与者在入组前通过关于知情同意书内容的口试，及格分数为15分中的12分（80%）。15名个体在与一名医生的单次会面中获得信息，其中3人（20%）通过。随后的30名志愿者由一名咨询师在三次会面中提供信息，24人（80%）通过。在欠发达国家的知情同意过程中，应将对研究参与者对知情同意书理解情况的正式评估视为常规步骤。
