Treating safety research like other clinical studies slows progress

While well-informed consent is crucial for all patients participating in new drug research, for example, it may not be necessary for studies like Pronovost’s research, in which the proposed intervention—a checklist to remember to follow steps, all known to make the ICU safer—is 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 don’t 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 little about the fact that many more people die in the hospital of medical errors than they do from lots of diseases,” she says.

“There is an ethical imperative to do patient safety research,” she adds. “We need to find a review system that works so that important research in this field won’t be compromised.”

Other authors of the article include Pronovost, leader of the 2006 checklist study; Jeremy Sugarman, M.D., M.P.H., M.A.; Christine A. Goeschel, R.N., M.P.A., M.P.S.; Lisa H. Lubomski, Ph.D.; and Ruth Faden, Ph.D.

For more information, go to:
http://www.bioethicsinstitute.org/
http://www.bioethicsinstitute.org/mshome/?id=65
http://www.safetyresearch.jhu.edu/QSR/Who/Team_Members/team_pronovost.asp
http://www.hopkinsmedicine.org/Press_releases/2006/12_27_06.html