On Friday, the U.S. Department of Health and Human Services posted an Advance Notice of Proposed Rulemaking (ANPRM), Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, to be published in the July 25 Federal Register.
The ANPRM seeks to "enhance the effectiveness of the research oversight system by improving the protections for human subjects while also reducing burdens, delays, and ambiguity for investigators and research subjects." In 92 pages, it suggests dozens of potential changes, some of them quite major. They would represent the biggest regulatory changes to the US IRB system since the revision of 45 CFR 46 in 1981.
Watch this space for extensive and frequent commentary on specific provisions in the proposal as I draft comments prior to the end of the 60 day comment period. (September 22? How do they count these things?)
For now, I will just register my delight that the federal government has finally acknowledged that the flaws in the present system are not mere anomalies, but represent systematic problems that demand regulatory reform.
Oh, and thanks for the three citations to my work! Attention has been paid!