Mason S A, Allmark P J
Northern and Yorkshire Clinical Trials and Research Unit, Leeds, UK.
Lancet. 2000 Dec 16;356(9247):2045-51. doi: 10.1016/s0140-6736(00)03401-2.
Questions have been asked about whether the process of obtaining informed consent from parents to clinical trials on neonates leads to valid consent. We undertook a study in nine European countries to assess this issue and to seek any practical improvements.
Semi-structured interviews were conducted with parents of 200 babies who had been asked for consent to neonatal trials and 107 neonatologists seeking consent. Analysis assessed the validity of the consent process against four components: parental competence; information given; parental understanding; and voluntariness of consent.
59 of the 200 parents had given valid consent or refusal but the remainder had problems in one or more of the component areas (42 for competence, 43 for information, 44 for understanding, and 21 for voluntariness). The proportions with impaired consent were greatest for research in an emergency situation and for that associated with risk or discomfort greater than standard treatment. Information sheets were little used by parents in deciding whether to consent. Parents highly valued their involvement in the informed consent process, and clinicians generally agreed on the value of the process.
Current standards of informed consent to neonatal research projects could be improved. Research personnel should receive guidance on legal and ethical constraints governing the process. Oral and written information should be given at the same time. Parents could be made aware that research projects have been examined by research ethics committees. Little support was found for the argument that informed consent should be relinquished for the parents' own good. Further study is needed to identify which elements of the process are valued by parents and clinicians in a process that has some unavoidable limitations.
关于从新生儿父母处获取临床试验知情同意的过程是否能产生有效同意，一直存在疑问。我们在9个欧洲国家开展了一项研究，以评估这一问题并寻求实际改进措施。
对200名被征求新生儿试验同意的婴儿的父母以及107名征求同意的新生儿科医生进行了半结构化访谈。分析根据四个要素评估同意过程的有效性：父母的能力；提供的信息；父母的理解；以及同意的自愿性。
200名父母中有59名给出了有效同意或拒绝，但其余父母在一个或多个要素领域存在问题（能力方面42名，信息方面43名，理解方面44名，自愿性方面21名）。在紧急情况下的研究以及与高于标准治疗的风险或不适相关的研究中，同意受损的比例最高。父母在决定是否同意时很少使用信息单。父母高度重视他们参与知情同意过程，临床医生普遍认同该过程的价值。
新生儿研究项目的现行知情同意标准可以改进。研究人员应接受关于该过程法律和伦理约束的指导。应同时提供口头和书面信息。可以让父母了解研究项目已由研究伦理委员会审查。几乎没有证据支持为了父母自身利益而放弃知情同意的观点。需要进一步研究，以确定在这个存在一些不可避免局限性的过程中，父母和临床医生看重该过程的哪些要素。
