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
by Susan Trinidad, MA, Research Scientist in the Department of Bioethics & Humanities at the Center for Genomics & Healthcare Equality at the University of Washington
Yesterday’s pre-conference program on centralized IRB review raised and clarified a number of issues I hadn’t considered [...] Read more
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.