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核医学中回旋加速器技术的伦理格局:国家与国际指南的比较分析

Ethical Landscape of Cyclotron Technology in Nuclear Medicine: A Comparative Analysis of National and International Guidelines.

作者信息

Khan Mohammad Nadeem

机构信息

Department of Pharmacology (Clinical Pharmacology), Sri Aurobindo Medical College & PG Institute, Sri Aurobindo University, Indore, Madhya Pradesh, India.

出版信息

Indian J Nucl Med. 2025 Mar-Apr;40(2):51-61. doi: 10.4103/ijnm.ijnm_146_24. Epub 2025 Jun 27.

Abstract

Cyclotron technology plays a pivotal role in nuclear medicine, enabling the production of radiopharmaceuticals for diagnostics and therapies. Despite its benefits, its application entails significant ethical challenges, particularly regarding patient safety, environmental protection, and compliance with regulatory standards. This article provides a detailed comparative analysis of the ethical landscape surrounding cyclotron use, highlighting key differences and alignments between Indian and international regulatory frameworks. The article examines ethical issues such as radiation exposure risks to patients, emphasizing safeguards such as as low as reasonably achievable principles and informed consent. It also explores the responsible use of radioactive materials in clinical and research contexts, along with specific measures for mitigating environmental contamination, such as waste management protocols and emission controls. A comprehensive review of India's regulatory frameworks, including the Atomic Energy Regulatory Board and the Department of Atomic Energy, is juxtaposed with international standards set by the International Atomic Energy Agency and the World Health Organization. The roles of these regulatory bodies are clarified, focusing on their mandates, overlaps, and potential conflicts in guideline interpretation. The article also underscores the critical role of institutional ethics committees in implementing ethical guidelines, monitoring compliance, and ensuring adherence to both national and international standards. By comparing ethical norms, the analysis identifies gaps in oversight and provides actionable recommendations for harmonizing protocols across jurisdictions. This study emphasizes the need for robust ethical frameworks in cyclotron technology to enhance patient safety, protect the environment, and ensure regulatory compliance. Such integration fosters trust and accountability while advancing nuclear medicine research and clinical applications.

摘要

回旋加速器技术在核医学中发挥着关键作用,能够生产用于诊断和治疗的放射性药物。尽管其具有诸多益处,但其应用带来了重大的伦理挑战,尤其是在患者安全、环境保护以及遵守监管标准方面。本文对围绕回旋加速器使用的伦理状况进行了详细的比较分析,突出了印度与国际监管框架之间的关键差异与一致性。文章审视了诸如患者辐射暴露风险等伦理问题,强调了如合理可行尽量低原则和知情同意等保障措施。它还探讨了在临床和研究环境中对放射性材料的负责任使用,以及减轻环境污染的具体措施,如废物管理协议和排放控制。对印度监管框架的全面审查,包括原子能监管委员会和原子能部,与国际原子能机构和世界卫生组织制定的国际标准并列呈现。明确了这些监管机构的作用,重点关注其任务授权、重叠之处以及在指南解释方面的潜在冲突。文章还强调了机构伦理委员会在实施伦理准则、监督合规情况以及确保遵守国家和国际标准方面的关键作用。通过比较伦理规范,分析找出了监管方面的差距,并为跨辖区协调协议提供了可操作的建议。这项研究强调了在回旋加速器技术中建立强有力的伦理框架对于提高患者安全、保护环境以及确保监管合规的必要性。这种整合在推进核医学研究和临床应用的同时,促进了信任和问责制。

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