[20160324]IF10380_在大健康数据时代更新通用规则.pdf

https:/crsreports.congress.gov March 24, 2016Updating the Common Rule in an Era of Big Health DataLast fall the Department of Health and Human Services (HHS) and 15 other federal departments and agencies jointly released a proposed rule to amend the uniform set of regulationsinformally known as the Common Rulethat govern the ethical conduct of research involving humans (80 Federal Register 53931, September 8, 2015). Federal regulations to protect human research subjects were first published by HHS in 1974 and revised in 1981 to implement the Belmont Report. That landmark report laid out an ethical framework for conducting human subject research based on the principles of (1) respect for persons (i.e., individuals are autonomous agents and should be given the opportunity to make informed choices based on their own judgment and opinions); (2) beneficence (i.e., the potential benefits of research should be maximized while minimizing the potential risks to research participants); and (3) justice (i.e., the benefits and the risks of research should be distributed fairly and not fall on one particular group). A modified version of the Common Rule was adopted by HHS and multiple other de