The IRB Nightmare: Navigating the Absurdity of US Human Subjects Research
The author recounts, in a lighthearted yet insightful manner, the complexities of Institutional Review Board (IRB) approval in US human subjects research. Using the analogy of an absurdly steep driveway, he illustrates the difficulty in comprehending the often illogical rules. The article debunks common misconceptions about IRB applicability, delving into the origins and intricacies of the Common Rule, and the added layer of FDA regulations. The author highlights the convoluted nature of current regulations, emphasizing that practical enforcement depends on selective application by regulatory bodies rather than strict adherence to written law. Ultimately, the author advocates for streamlining IRB processes, particularly for low-risk research, suggesting a post-hoc penalty system rather than pre-approval.