Nat Genet. 2011 Aug 29;43(9):817. doi: 10.1038/ng.933.
The US Department of Health and Human Services (DHHS) is proposing to enhance federal regulation intended to protect human research subjects, in particular to increase measures aimed at security of personal data. Since the ethical review process is partially based on respect for people and their autonomy, harmonization of these rules will be a process of convincing individuals and their states to accept uniform standards that give enough privacy but do not lock away personal data from either research participants or researchers.
美国卫生与公众服务部(DHHS)提议加强旨在保护人类研究对象的联邦法规,特别是增加旨在保护个人数据安全的措施。由于伦理审查过程部分基于对人和他们的自主权的尊重,因此协调这些规则将是一个说服个人及其所在州接受统一标准的过程,这些标准既要给予足够的隐私保护,又不能将个人数据与研究参与者或研究人员隔离开来。