Federal officials have dropped a controversial plan to impose new rules that researchers say would have made it much harder to use patient blood and tissue samples in research. The final Common Rule released this morning omits these provisions, but leaves some other changes intact.
Biomedical and university research groups that lobbied against the biospecimens provisions are relieved. “We are very pleased at the amount of time, attention, and effort that went into reviewing the comments. The process worked,” says Lizbet Boroughs, who follows biomedical research policy for the Association of American Universities in Washington, D.C.
The 26-year-old Common Rule protects people who volunteer for federally funded research studies. The Department of Health and Human Services (HHS) and other agencies began an overhaul in 2011 to incorporate changes in how medical research is done, such as a growing number of clinical trials, the use of electronic medical health records, and privacy concerns raised by advances in genomics.
Other news about the update to the US ‘Common rule’
- Proposed US Federal Policy for the Protection of Human Subjects (‘The Common Rule’) August 2015
- Deregulating Social Science Research Ethics – Clipping the Wings of IRBs? – Social Science Space (Robert Dingwall | November 2015)
- Reform of Clinical Research Regulations, Finally (PAPERS: E. J. Emanuel, M.D | November 2015)
- Common Rule Revision – The Ethics Police Fight Back – Social Science Space (Robert Dingwall | December 2015)
- AAA Comments on Notice of Proposed Rule Making for IRBs (Papers: Rena Lederman & Lise Dobrin | January 2016)
- Science academies blast US government’s planned research-ethics reforms – Nature (Sara Reardon | June 2016)
- HHS and 15 other Federal Departments and Agencies Announce Revisions to the US Federal Policy for the Protection of Human Subjects (the Common Rule) – Statement from the HHS | January 2017
- Common Rule Reform – A Botched Job – Network Blogger (Robert Dingwall | January 2017)