Human Subject Protection

Your article "Monitoring Human Subjects and Clinical Trials"1 reports on the findings of the Health and Human Services Inspector General concerning institutional review boards and determines that "many IRBs aren't getting the job [of protecting human subjects] done." The article mentions only one researcher whose procedures were criticized recently (and then we don't hear his side). We never know what got Duke University and University of California, Los Angeles, into trouble. Was it callous or

David Cameron Duffy
Jul 23, 2000

Your article "Monitoring Human Subjects and Clinical Trials"1 reports on the findings of the Health and Human Services Inspector General concerning institutional review boards and determines that "many IRBs aren't getting the job [of protecting human subjects] done." The article mentions only one researcher whose procedures were criticized recently (and then we don't hear his side). We never know what got Duke University and University of California, Los Angeles, into trouble. Was it callous or illegal treatment of patients or was it not "properly filling out and filing informed consent forms"?

A slightly deeper article would have asked how many abuses really occur, out of all the research being done; or, how many involved abuses of patients and how many [involved] abuses of paperwork? The article might have asked whether lab scientists saw the process as necessary, sufficient, or even effective. It might also have wondered if regulators are...

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