残疾儿童康复研究伦理审查的挑战与思考

doi:10.3969/j.issn.1006-9771.2026.02.003

摘要/Abstract

摘要：

目的探讨开展残疾儿童康复研究的正当性和特殊性，剖析残疾儿童参与康复研究项目伦理审查的核心症结。

方法从政策法规和医学伦理基本原则等理论层面，阐明残疾儿童参与康复研究的正当性和必要性。基于残疾儿童的生理特征、心理特点和认知能力等方面的特殊性，系统梳理残疾儿童康复研究伦理审查的核心挑战，包括研究风险评估与防控不足、知情同意决策困难、儿童主体性被忽视、特殊群体保障缺乏、研究实施过程存在隐性风险等，结合伦理审查要点展开针对性分析。

结果残疾儿童康复研究契合特殊群体健康权益保障需求，具备充分的正当性。但由于残疾儿童在认知能力、自主决策和权益保障等方面的特殊性，使其伦理审查面临诸多核心挑战，需要采取相应对策。

结论残疾儿童康复研究的伦理审查需充分兼顾研究正当性和参与者特殊性，通过健全伦理审查制度体系，强化顶层设计；聚焦核心挑战，比如建立风险评估和防控机制、优化知情同意和残疾儿童主体性保障机制、加强隐性风险防控和研究者队伍建设；提升伦理审查能力、强化研究过程监管等举措，实现研究科学性与伦理合理性的统一，推动该领域研究规范有序发展。

关键词: 残疾儿童, 康复研究, 伦理审查, 知情同意, 风险评估

Abstract:

Objective To explore the legitimacy and particularity of conducting rehabilitation research for children with disabilities, and analyze the core cruxes in the ethical review of such children's participation in rehabilitation research projects.

Methods From the theoretical perspectives of policies and regulations as well as the basic principles of medical ethics, the legitimacy and necessity of children with disabilities participating in rehabilitation research were clarified. Based on the particularities of children with disabilities in terms of physiological characteristics, psychological traits and cognitive abilities, the core challenges in the ethical review of rehabilitation research for this group were systematically sorted out, including inadequate assessment and prevention of research risks, difficulties in informed consent decision-making, neglect of children's subjectivity, lack of safeguards for special groups and hidden risks in the research implementation process. Targeted analyses were then conducted in combination with the key points of ethical review.

Results Rehabilitation research for children with disabilities aligns with the demand for safeguarding the health rights and interests of special groups and thus has sufficient legitimacy. However, the particularities of children with disabilities in cognitive abilities, independent decision-making and rights protection expose the ethical review of such research to numerous core challenges, which call for corresponding countermeasures.

Conclusion The ethical review of rehabilitation research for children with disabilities must fully balance research legitimacy with the particularities of participants. It is necessary to unify research scientificity with ethical rationality and promote the standardized and orderly development of research in this field through multiple measures: improving the institutional system of ethical review and strengthening top-level design; focusing on core challenges such as establishing a research risk assessment and prevention mechanism, optimizing the mechanisms for informed consent and the protection of children with disabilities' subjectivity, and enhancing the prevention of hidden risks and the construction of research teams; and raising the capacity of ethical review and strengthening the supervision of the research process.

Key words: children with disabilities, rehabilitation research, ethical review, informed consent, risk assessment

中图分类号:

孟丽君. 残疾儿童康复研究伦理审查的挑战与思考[J]. 《中国康复理论与实践》, 2026, 32(2): 142-150.

MENG Lijun. Challenges and reflections on ethical review of rehabilitation research for children with disabilities[J]. Chinese Journal of Rehabilitation Theory and Practice, 2026, 32(2): 142-150.

图/表 1

表1

我国近10年儿童临床研究国家层面的政策文件"

政策编号	政策名称	发文机构	发文时间
P1	儿科人群药代动力学研究技术指导原则	国家食品药品监督管理总局	2014
P2	关于保障儿童用药的若干意见	国家卫生计生委、国家发展改革委、工业和信息化部、人力资源社会保障部、国家食品药品监管总局、国家中医药管理局	2014
P3	儿科人群药物临床试验技术指导原则	国家食品药品监督管理总局	2016
P4	关于深化审评审批制度改革鼓励药品医疗器械创新的意见	中共中央办公厅、国务院办公厅	2017
P5	中华人民共和国药品管理法	全国人大常委会	2019
P6	中华人民共和国药品管理法实施条例	国务院	2019
P7	儿科用药临床药理学研宄技术指导原则	国家药品监督管理局药品审评中心	2020
P8	药品注册管理办法	国家市场监督管理总局	2020
P9	药物临床试验质量管理规范	国家药品监督管理局、国家卫生健康委员会	2020
P10	儿童用化学药品改良型新药临床试验技术指导原则(试行)	国家药品监督管理局药品审评中心	2021
P11	罕见疾病药物临床研发技术指导原则	国家药物监督管理局药品审评中心	2021
P12	注意缺陷多动障碍(ADHD)药物临床试验技术指导原则(试行)	国家药品监督管理局药品审评中心	2021
P13	医疗器械临床试验质量管理规范	国家药品监督管理局、国家卫生健康委员会	2022
P14	儿童抗肿瘤药物临床研发技术指导原则	国家药物监督管理局药品审评中心	2023
P15	涉及人的生命科学和医学研究伦理审查办法	国家卫生健康委员会、教育部、科技部、国家中医药管理局	2023
P16	生理药代动力学模型在儿科人群药物研发中应用的技术指导原则	国家药品监督管理局药品审评中心	2023
P17	以患者为中心的药物临床试验实施技术指导原则(试行)	国家药品监督管理局药品审评中心	2023
P18	医疗卫生机构开展研究者发起的临床研究管理办法	国家卫生健康委员会、国家中医药局、国家疾控局	2024
P19	医疗卫生机构开展研究者发起的中医药临床研究管理办法	国家中医药管理局	2025

表1

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