This would be the most significant change in 30 years, which the Department of Health and Human Services will begin considering at the end of a 60 day comment period beginning on Monday. Why the rush?
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… 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.
The full press release is here. They’re asking for public comments on a range of issues, starting with “revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.” Some time in the distant future, scholars might be allowed to forgo creating 24-hour help lines in case subjects get traumatized by listing their top 3 news sources.
Probably unhelpful is my usual response to IRB issues, which is that 19 year olds are made of rubber.
Photo:
* Thomas Ihle [Wiki Commons]
References:
* Feds Ponder Biggest IRB Rules Changes in 30 Years! [Institutional Review Blog]
* HHS announces proposal to improve rules protecting human research subjects [HHS.gov]
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