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Treating safety research like other clinical studies slows progress
Date:5/13/2008

icipated wasnt required. However, after the anonymous complaint, the federal Office for Human Research Protections, a branch of the U.S. Department of Health and Human Services that oversees IRBs, determined that patient consent and Michigan hospital IRB review should have taken place.

According to Kass, who served for more than 10 years on a Johns Hopkins IRB and is an expert in the ethics of human research, such a decision ignores the differences between patient safety research of this sort and other types of research that include riskier and more burdensome interventions and procedures, such as human trials for new drugs.

While well-informed consent is crucial for all patients participating in new drug research, for example, it may not be necessary for studies like Pronovosts research, in which the proposed interventiona checklist to remember to follow steps, all known to make the ICU saferis virtually risk-free, where data are lumped together so individual patients names and information are never collected, and where the consent process may be burdensome to very sick patients. Also, according to Kass, since many small hospitals dont have IRBs, requiring every hospital to get an IRB review for patient safety evaluations would hinder many hospitals from participating in these studies and contributing their experiences to widespread evaluations.

All of us want to make sure that patients are protected in any type of research, said Kass, but it is also critical to recognize which studies are low risk and should easily move through the system, and which ones are high risk and require considerably more scrutiny.

Kass adds that working through these issues is crucial to advancing patient safety research, a field that has the potential to greatly advance public health.

When the public thinks about important medical research, they might think about a cure for a horrible disease. I think the average person has heard very li
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Contact: Christen Brownlee
cbrownlee@jhmi.edu
410-955-7832
Johns Hopkins Medical Institutions
Source:Eurekalert

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