Tag Archives: human subjects research

Is your research a clinical trial? The answer may surprise you!

Background In October 2014, the National Institutes of Health (NIH) announced a change in its definition of a clinical trial, to take effect in January 2015. The new definition, which applies only to NIH-funded clinical trials, reads: “A research study in which one or more human subjects are prospectively assigned to one or more interventions… Read More »

National Academies Committee Calls for New Review of Human Subjects Research

On June 29, the National Academies of Science, Engineering, and Medicine released the final version of “Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century.” The Academies report calls for the creation of an independent national commission charged with fully examining the regulatory, legal, and ethical dimensions to research… Read More »

Common Rule in the news as deadline approaches

As the January 6 deadline for submitting comments on proposed updates to human subjects research regulations loomed, popular media took notice. Just last week the New York Times and Forbes published commentaries on the strengths and weaknesses of both the current and proposed rules. Federal human research protection regulations have been on the books since… Read More »

FASEB tackles human subject research protections

On November 11, the Federation of American Societies for Experimental Biology (FASEB) submitted feedback  to the Department of Health and Human Services (HHS) on proposed changes to Federal Policy for the Protection of Human Subjects. The agency issued the modifications in an effort to improve protection for those who participate in research studies while simultaneously easing oversight… Read More »