摘要
《个人信息保护法》“强化两头,多方平衡”。医学科研中的个人信息处理应以保护受试者个人信息权益为前提,平衡好各方合法权益。个人信息的界定采关联说,编码信息属于个人信息。医学研究应遵守个人信息处理规则,处理个人信息应当有合法依据,要么取得受试者明确同意,要么有法律许可。医学研究中的个人信息往往既是敏感信息,也是私密信息,故对受试者个人权益往往有重大影响,需要在处理前进行评估,严格履行《个人信息保护法》规定的个人信息处理者义务,依法保障受试者在个人信息处理活动中的法定权利。《个人信息保护法》对科学研究中的泛化同意未予认可,不符合医学科研的特点,不利于科学创新,值得商榷。
The Personal Information Protection Law"strengthens the two ends and balances multiple parties".Personal information processing in medical research should be based on the protection of the subjects'personal information rights and interests,and the legitimate rights and interests of all parties should be balanced.The definition of personal information adopts the related theory,and the coded information belongs to personal information.Medical research should comply with personal information processing rules.The processing of personal information should have a legal basis,either obtain the explicit consent of the subjects or have legal permission.Personal information in medical research is often both sensitive information and private information,so it often has a significant impact on the personal rights and interests of subjects.It needs to be evaluated before processing and strictly fulfill the personal information processor obligations under the Personal Information Protection Law.The legal rights of subjects in personal information processing activities shall be protected in accordance with the law.The Personal Information Protection Law does not recognize broad consent in scientific research,which does not conform to the characteristics of medical scientific research,is not conducive to scientific innovation,and is worthy of discussion.
作者
刘瑞爽
Liu Ruishuang(Peking University Health Science Center,Beijing100191,China)
出处
《中国卫生法制》
2023年第4期17-21,共5页
China Health Law
关键词
个人信息保护法
个人信息
医学研究
伦理审查
知情同意
个人信息保护权
Personal Information Protection Law
Personal information
Medical research
Ethical review
Informed consent
The right to personal information protection right
