[20181210]IF11043_更新的通用规则：使用储存的生物样品进行研究的关键变化 .pdf

https:/crsreports.congress.gov December 10, 2018Updated Common Rule: Key Changes for Research Using Stored Biospecimens On January 19, 2017, the Department of Health and Human Services (HHS) and 15 other federal departments and agencies jointly published a final rule to amend the uniform set of regulationsknown as the Common Rulethat govern the ethical conduct of research supported by these agencies involving humans (82 Federal Register 7149). According to HHS, the purpose of the final rule is to modernize, simplify, and strengthen the Common Rule to better protect human research subjects, while facilitating new research and reducing burden and ambiguity for investigators. The Common Rule had remained virtually unchanged since it was adopted in 1991, while the research landscape has undergone significant transformation. Traditionally, the Common Rule has protected the rights and welfare of individuals participating in clinical trials and other interventional research. However, much of todays health research involves the analysis of health information rather than direct interactions with research subjects due to the growth in health data analytics, that is, using large databases of