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.
By: Wendy Tate, PSM, CIP
The February 2011 issue of Health Affairs published an article criticizing the Food and Drug Administration (FDA)’s humanitarian device exemption (HDE) for deep-brain stimulation in patients with treatment-resistant obsessive-compulsive disorder (OCD). According to Read more
(Originally posted by the Northwest Association for Biomedical Research)On Tuesday, April 14, officials at the Food and Drug Administration issued a warning letter to Coast IRB in response to their recent approval of a fake device study submitted by the Government Accountability Office. As a result Coast IRB has voluntarily agreed to review no new studies or enroll new subjects into ongoing protocols, both under 21 CFR Part 56.
