摘要
美国保护人体受试者的制度建立在伦理学基础之上 ,并正式通过相关法律。对人体研究的监督是保护受试者个人的健康和权益 ,确保研究的有效性、整体性 ,以及科学与社会更大范围的利益。监督审查机构是联邦卫生部下属的两个机构———食品与药品管理局 (FDA)和人体研究保护办公室 (OHRP) ,大部分人体研究受两机构监督。美国人体受试者保护系统的基础部分是伦理审查委员会 (IRB)及知情同意。IRB意在提供一种机制 ,以进行客观的审查、同意和研究过程的持续监督 ;知情同意意在保证个人在了解与实验相关的风险、不适、收益后能自由做出参加与否的决定。美国人体研究保护制度正面临着挑战 ,美国也为促进人体受试者保护在进行新的努力。
The US system for protection of human subjects is based on ethics,but formally established through statutes and regulations.The oversight human research is to protect the rights and welfare of individual research participants,and to ensure the validity and integrity of research for protecting the broader interests of science and society.The oversight agencies are two agencies within the department of Health and Human Services (HHS),the Food and Drug Administration (FDA),and the Office for Human Research Protections (OHRP).Most human research subject to govenment regulations is overseen by either one of the two agencies.The cornerstones of the human subject protection system in the US are the Institutional Review Board (IRB) and Informed Consent.IRB is intended to provide a mechanism for objective review,approval and continuing oversight of human research.While the process of informed consent is intended to insure that individual decisions regarding particication are made freely with an appreciation for the risks,discomforts and benefits,if any,related to participation the study.The current challenges are facing the US system of human subject protection.We have adopted ongoing effort by a simpler,more uniform efficient and effective system in order to improve human subject protection.
出处
《医学与哲学》
2001年第12期11-13,共3页
Medicine and Philosophy
关键词
人体研究监督
人体受试者
保护
伦理审查委员会
知情同意
oversight of human research
human subjects protection
institutional review boards
informed concent
