Leach A, Hilton S, Greenwood B M, Manneh E, Dibba B, Wilkins A, Mulholland E K
Medical Research Council Laboratories, Fajara, The Gambia, West Africa.
Soc Sci Med. 1999 Jan;48(2):139-48. doi: 10.1016/s0277-9536(98)00317-7.
It has recently been debated whether it is possible or desirable to have one internationally recognised standard of "informed consent" or whether research ethics should be adapted to the culture and educational level of the study population. This study examined the attitudes of the Gambian people to consent to medical research, and evaluated the informed consent process used in a major efficacy trial of a Haemophilus influenzae vaccine. Consent was requested after parents had received a verbal explanation and an information sheet which described the vaccine trial in a local language. A semi-structured interview was conducted with 137 acceptors and 52 refusers. Certain points of knowledge were recalled well by the acceptors; 90% knew the purpose of the vaccine was to prevent disease, but the placebo control design was understood by only 10%. The prime motive for consenting was to receive the HIB vaccine (93%) and that for refusing was that the vaccine was experimental (35%) and might have unknown side effects (29%). Although parents took advice from researchers (50%), health workers (24%), friends (16%) and family (12%), in all cases the decision was made by one of the child's parents. Only 1% of parents sought the opinion of traditional or religious leaders. The principles of informed consent, that it should be free, autonomous and informed were affirmed by this community. Therefore, in The Gambia, the international code of informed consent is appropriate.
最近，人们一直在争论是否有可能或是否应该有一个国际认可的“知情同意”标准，或者研究伦理是否应该根据研究人群的文化和教育水平进行调整。本研究调查了冈比亚人民对医学研究同意的态度，并评估了一项流感嗜血杆菌疫苗主要疗效试验中使用的知情同意过程。在父母收到口头解释和用当地语言描述疫苗试验的信息表后，征求他们的同意。对137名同意者和52名拒绝者进行了半结构化访谈。同意者对某些知识要点的记忆良好；90%的人知道疫苗的目的是预防疾病，但只有10%的人理解安慰剂对照设计。同意的主要动机是接种HIB疫苗（93%），拒绝的主要动机是疫苗是试验性的（35%），可能有未知的副作用（29%）。虽然父母会听取研究人员（50%）、卫生工作者（24%）、朋友（16%）和家人（12%）的建议，但在所有情况下，决定都是由孩子的父母之一做出的。只有1%的父母征求传统或宗教领袖的意见。这个社区肯定了知情同意的原则，即它应该是自由、自主和知情的。因此，在冈比亚，国际知情同意准则是合适的。
