[ Tuesday, June 10, 2003 ]


You knew this would happen:

Here's an article (registration may be required, but it's free) about the trouble researchers are having with HIPAA. If you need an authorization before you even look at the records to see if there are any patients that might be useful in a clinical trial. Of course, you can avoid that route if an Institutional Review Board gives a wiaver for researchers to do this pre-investigative look. But if the IRB is jittery, you're stuck. It shouldn't be a problem getting patients to authorize this type of helpful, non-intrusive pre-investigative review, should it? It wouldn't, if there was someone who could spend 10 or 15 minutes explaining to the patient that the review will be done be a researcher, it's just to see who among the clinic patients might fit the profile for a particular study, and would not involve the patient's information being disclosed to anyone other than the researcher (who would only contact the patient's physician if the patient fit the right profile). The problem is 10-15 minutes multiplied by 10,000 patients in the clinic equals a year's salary of a staff member.

Perhaps as IRBs and clinical researchers figure out how and when to grant waivers, the process will re-streamline itself. Until then, it's another fine example of the law of unintended consequences.

Jeff [9:40 AM]

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