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Sunday, March 19, 2017

Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations

James G. Hodge Jr. and Lawrence O. Gostin
JAMA. Published online February 22, 2017

On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services, and 15 federal agencies published a final rule to modernize the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”).1 Initially introduced more than a quarter century ago, the Common Rule predated modern scientific methods and findings, notably human genome research.

Research enterprises now encompass vast multicenter trials in both academia and the private sector. The volume, types, and availability of public/private data and biospecimens have increased exponentially. Federal agencies demanded more accountability, research investigators sought more flexibility, and human participants desired more control over research. Most rule changes become effective in 2018, giving institutions time for implementation.

The article is here.