[20170516]IF10653_更新的通用规则：利用储存的生物样品进行研究.pdf

https:/crsreports.congress.gov May 16, 2017Updated Common Rule: Research Using Stored BiospecimensOn 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). The Common Rule has remained virtually unchanged since it was adopted in 1991, while the research landscape has undergone enormous transformation. One key area of change is the rapid growth of research involving biospecimens (e.g., human blood, tissue, and other biological specimens), which increasingly are collected and used for whole genome sequencing and other genetic analysis. Repositories store biospecimens for possible use in future (i.e., secondary) research that may be unrelated to the clinical or research use of the material at the time it was collected. The All of Us research programpart of the Precision Medicine Initiative to accelerate research on personalized treatments tailored to a patients genetic and other characteristicsseeks to establish a nati