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儿童和青少年人体研究的伦理准则:一项叙述性综述研究。

Ethical guidelines for human research on children and adolescents: A narrative review study.

作者信息

Askari Gholamreza, Vajdi Mahdi, Jafari-Nasab Saeede, Golpour-Hamedani Sahar

机构信息

Department of Community Nutrition, Nutrition and Food Security Research Center, School of Nutrition and Food Science, Isfahan University of Medical Science, Isfahan, Iran.

Student Research Committee, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

J Res Med Sci. 2024 Aug 2;29:53. doi: 10.4103/jrms.jrms_610_23. eCollection 2024.

Abstract

The implementation of human research involving children and adolescents necessitates a nuanced understanding of the distinct ethical complexities and sensitivities that arise. This study aimed to conduct a comprehensive review of ethical guidelines for research with these populations by extensively examining existing standards and applied studies. The review revealed a myriad of challenges inherent in the involvement of children and adolescents as research subjects. The most important ethical challenges relate to the principles of bioethics and their compliance with human studies involving children/adolescents, informed consent, and risk assessment in studies on children/adolescents. To facilitate appropriate participation of youth in research endeavors, meticulous planning is required, in conjunction with a re-examination of the definitions of ethical principles in pediatric research, close monitoring of potential risks and benefits, and the utilization of a combination of innovative and traditional approaches to obtain informed consent that adheres to ethical standards. Performing research with children and adolescents requires special considerations to address the unique ethical issues that can emerge. By adhering to ethical guidelines tailored specifically to these vulnerable populations, researchers can help ensure that studies are conducted in an appropriate and responsible manner.

摘要

涉及儿童和青少年的人体研究的实施需要对所出现的独特伦理复杂性和敏感性有细致入微的理解。本研究旨在通过广泛审查现有标准和应用研究,对针对这些人群的研究伦理准则进行全面综述。该综述揭示了儿童和青少年作为研究对象所固有的众多挑战。最重要的伦理挑战涉及生物伦理原则及其在涉及儿童/青少年的人体研究中的遵循情况、知情同意以及儿童/青少年研究中的风险评估。为了促进青少年适当参与研究工作,需要精心规划,同时重新审视儿科研究中伦理原则的定义,密切监测潜在风险和益处,并采用创新方法与传统方法相结合的方式来获得符合伦理标准的知情同意。对儿童和青少年进行研究需要特殊考虑,以解决可能出现的独特伦理问题。通过遵循专门针对这些弱势群体制定的伦理准则,研究人员可以帮助确保研究以适当和负责任的方式进行。

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