CAJ | 학술논문

我国对于医学临床试验研究受试者的保护仍存在研究者和受试者认知有偏差、知情同意落实难、后续跟踪审查乏力等问题。基于美国经验和国内某医院的探索，提出完善我国受试者保护的建议：建立多部门协作的受试者保护体系；提高受试者的法律意识和维权意识；伦理委员应实地考察、保证审查质量；建立强制保险制度；建立药品不良反应救济制度。
아국대우의학림상시험연구수시자적보호잉존재연구자화수시자인지유편차、지정동의락실난、후속근종심사핍력등문제。기우미국경험화국내모의원적탐색，제출완선아국수시자보호적건의：건립다부문협작적수시자보호체계；제고수시자적법률의식화유권의식；윤리위원응실지고찰、보증심사질량；건립강제보험제도；건립약품불량반응구제제도。
Clinical trials for medical research subjects of protection in China is still the researchers and sub-jects′cognitive biases, informed consent to carry out the difficult and the lack of follow-up tracking examination questions.Based on the experience and the domestic exploration of a hospital, put forward the Suggestions of per-fecting our country′s subjects protection: establish multi-sectoral cooperation of the subjects protection system, improve the legal consciousness and the consciousness of the subjects, the ethics committee should be field trips, build system of compulsory insurance, adverse drug reaction relief system is established.