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<p>A clinical trial that involved studying electronic health record alerts for acute kidney injury seemed to be minimal risk to both the researchers and the IRBs that approved it. However, when two hospitals involved in the study reported an increased mortality rate, the researchers and the IRBs reconsidered what is truly minimal risk in these types of studies.</p>

Researchers and IRBs Reconsider Minimal Risk After Trial Results

Increased mortality rate in some hospitals led to new IRB monitoring and oversight