Tag Archives: human subjects

NIMH Announces Data Sharing Policy

July 3, 2019

The National Institute of Mental Health has recently announced that researchers who are funded by NIMH will be required to deposit all raw and analyzed data (including, but not limited to, clinical, genomic, imaging, and phenotypic data) from experiments involving human subjects into an informatics infrastructure which will enable the sharing and use of this […]

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The Revised Common Rule is Almost Here!

December 21, 2018

Effective January 21, 2019, human subjects research is subject to revised regulations. *Please note that FDA has not yet harmonized, so parts of the new Rule cannot be applied to FDA-regulated research.* Details are available in our recent webinars here: http://irb.emory.edu/Training/webinars.html. What will you see in eIRB? If you submit, or edit a new submission, after […]

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TRANSITION OF NIH INCLUSION MANAGEMENT SYSTEM TO NEW HUMAN SUBJECTS SYSTEM (LIVE 6/8/18)

May 29, 2018

The National Institutes of Health has recently announced that it will replace the current Inclusion Management System (IMS) which is used to report the sex/gender, race, and ethnicity of participants in human subjects research studies. The new system will be the Human Subjects System (HSS). The HSS will consolidate human subjects and clinical trial information […]

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Important News About NIH-Funded Human Subjects Research

November 1, 2017

NIH Policy for NIH-Funded Human Subjects Research Effective October 1, 2017, all new and ongoing NIH-funded research meeting certain criteria is deemed to be issued a Certificate of Confidentiality (CoC) via a new NIH policy. This policy results from a directive in the 21st Century Cures Act. For more information about the change in policy, please see this notice. Previously, researchers […]

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