儿科的临床科研伦理问题及其解决方案综述

Review of Ethical Problems and Solutions in Pediatric Clinical Research

临床科研中伦理问题受到广泛关注,尤其是患者数量多、医疗复杂性高的儿科。在知情同意中,做出同意的人在身份或能力上可能不适合而且知情不充分或者焦虑和压力等因素可能会影响其做出决定;在伦理审查中,儿科知情同意程序、儿童护理条件、报销赔偿标准复杂而且部分伦理委员会对儿科的特殊性了解不深;在儿科伦理咨询中,有关信息少、利用不充分、地域差异大。知情同意中的问题可由使用双重同意程序或评估儿童是否具有同意能力、研究员与做出同意的人沟通并强调风险并在特殊情况下使用延期同意解决;伦理审查中的问题可由建立中央伦理委员会并与社会伦理委员会合作、建立规范并进行培训解决;伦理咨询中的问题可由使用电子咨询、制定伦理咨询程序解决。

In clinical research,ethical issues have attracted wide attention,especially in pediatrics with a large number of patients and high medical complexity. In informed consent,the person who makes consent may not be suitable in identity or ability,and the factors such as insufficient knowledge,anxiety and pressure may affect his decision-making. In the ethical review,the procedure of informed consent in pediatrics,the conditions of child care and the standard of compensation for reimbursement are complicated,and some ethical committees do not have a deep understanding of the particularity of pediatrics. In pediatric ethical counseling,there are few relevant information,insufficient utilization and great regional differences. Problems in informed consent can be solved by using double consent procedure or assessing children’s ability to consent,communicating with consenting people and emphasizing risks,and using deferred consent in exceptional cases. The problems in ethical review can be solved by establishing a central ethics committee and cooperating with the social ethics committee,establishing norms and training,and the problems in ethical consultation can be solved by using electronic consultation and establishing ethical consultation procedures.