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View Full Version : Does IRB(institutional review board ) act with benevolent observers or malignant intervenors ?



Tangri
30th January 2013, 14:57
An institutional review board (IRB), also known as an independent ethics committee or ethical review board, is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans. They often conduct some form of risk-benefit analysis in an attempt to determine whether or not research should be done.[1] The number one priority of IRBs is to protect human subjects from physical or psychological harm. In the United States, the Food and Drug Administration (FDA) and Department of Health and Human Services (specifically Office for Human Research Protections) regulations have empowered IRBs to approve, require modifications in planned research prior to approval, or disapprove research. IRBs are responsible for critical oversight functions for research conducted on human subjects that are 'scientific', 'ethical', and 'regulatory'.
Although designed to protect the rights and welfare of the research subjects, IRBs have been criticized by bioethicists for conflicts of interest resulting in lax oversight. As of 2005, the for-profit Western Institutional Review Board claimed to conduct the majority of reviews for new drug submissions to the FDA.
In a 2006 study of 575 IRB members at university medical centers, over one-third reported industry financial ties and over one-third admitted they "rarely or never" disclosed conflicts of interest to other board members.
A 2009 sting operation by the Government Accountability Office led Coast IRB to shut down after approving the fake product "Adhesiabloc", called "the riskiest thing Iíve ever seen on this board" by one of the IRBs not approving the fake product