On September 8, 2015, the Department of Health and Human Services (HHS) and 15 other federal departments and agencies issued a proposal to revise the regulations governing the ethical conduct of ...

To comply with the 21st Century Cures Act, 1 the Food and Drug Administration (FDA) has released two Notices of Proposed Rulemaking (NPRMs). NPRMs are the initial public notice of a proposed change to ...

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of ...

The Common Rule describes the basic DHHS policy for the protection of human research participants and is incorporated into University policy for: IRB review types and processes; criteria for IRB ...

JURIST Guest Columnists James G. Hodge, Jr., Sarah Arnold and Sarah Wetter of The Sandra Day O’Connor College of Law, Arizona State University, discuss premier takeaways from the recent amendments to ...

In a final rule published on January 19, 2017, HHS and several federal departments and agencies made revisions to the Common Rule, the federal policy for the protection of human subjects applicable to ...

The federal regulations for the protection of human subjects (Common Rule) were revised effective January 20, 2019 to reduce administrative burdens for low-risk research while enhancing protections ...

Recently proposed changes to the “Common Rule” by the U.S. Department of Health and Human Services (HHS) and various other federal agencies, while aiming to enhance human subject protections for ...

The Common Rule, initially adopted in 1991, created an overarching guideline for federally funded human subjects research to provide oversight both in response to prior ethical transgressions and to ...