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ResourcesHuman Research EthicsHHS 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

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

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

 


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The U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies have announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. This final rule is intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

This change applies only to research that is reviewed by an IRB/research ethics committee that utilises the HHS framework. Nevertheless it might portend changes to the frameworks in other jurisdictions.

These revisions are an effort to modernize, simplify, and enhance the current system of oversight.
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The final rule is being put on public display on January 18, 2017, by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents…. It is expected that the final rule will be published in the Federal Register on January 19, 2017.
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HHS released a Press Release about the final rule that can be accessed at: https://www.hhs.gov/about/news/2017/01/18/final-rule-enhances-protections-research-participants-modernizes-oversight-system.html.



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