ISTOCK, BOJAN89
Last week, the US Department of Health and Human Services and 15 government agencies issued a six-month delay to proposed changes to the Common Rule—a federal policy regulating the use of human research subjects—that were set to go live last Friday (January 19). This delay, the agencies write in a statement, would provide additional time for “interested stakeholders” to provide feedback and for research institutions to prepare for the proposed changes. The new effective date for the changes is July 19.
The proposed revisions include stricter rules for informed consent, such as requirements to post brief, comprehensive study summaries at the tops of consent forms and to obtain permission to use stored, unlabeled biospecimens leftover after clinical use. They also include changes to the institutional ...
