TAG ARCHIVES FOR FDA

16
Mar2013

On February 28, 2013, PRIM&R hosted a webinar titled Key Decision Points: Is it Research Involving Human Subjects? It is Exempt? Is IRB Review Required? Following the webinar, I had a chance to connect with the presenters, Karen Hale, RPh, MPH, CIP, and Daniel Nelson, MSc, CIP, to discuss some of the questions that came in that they were unable to cover during the allotted time. Below, they share their perspectives on a few of the questions.

Q: Why can't I determine if a study involves "human subjects" before I determine if it is "research"?

A: From a regulatory standpoint, the definition of a “human [...] Read more

14
Dec2012

by Andrea Johnson, JD, CIP, Regulatory Specialist in the Research Integrity Office at Oregon Health and Science University 

Personalized medicine is an exciting and growing focus of clinical research. It frequently involves the use of an in vitro diagnostic test (IVD) to identify biological or genetic characteristics about an individual that can predict how a person will respond to different [...] Read more

8
Dec2012

by Rebecca Boxhorn, JD, Research Associate at the Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota

The second day of the 2012 Advancing Ethical Research (AER) Conference got off to an engaging start thanks to the Keynote Address given by Dr. James R. Gavin III, executive vice president and chief medical officer [...] Read more

22
Oct2012

Autumn may be here, but the leaves are not the only things turning heads this week. Peruse the latest installment of the Research Ethics Roundup for some colorful articles, including a fresh perspective on the purported rise of fraud in research, an essay on the role of institutional review boards (IRBs) in social science, and much more.

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