“I believe you have an ethical obligation to share what you learn with other hospitals,” says Dr. Lindenauer. “So, of course, you want to write it up. But once you start to talk about publication and sharing you start to get to the point where you’re crossing the line —where you’re creating generalizable knowledge.”
And that is precisely when government organizations like the OHRP think you’ve crossed over into research, Dr. Lindenauer says. “It’s a tricky question,” he adds.
Ethicist Baily agrees that experts need to work on coming up with a practical definition of research. Right now, the situation is impossible, she says. Take, for example, a medical plan that wants to send postcards to encourage patients to show up for an annual physical. If researchers want to learn whether that technique works, do they need to send a postcard, prior to the reminder postcard, to let patients know that they’re going to be part of a study, she asks.
And even more important, with all the staff cuts at medical institutions around the country, shouldn’t QI officers study whether these cost-cutting measures adversely affect patient care, she asks. TH
Linda Carroll is a medical journalist based in New Jersey.
- Ness RB, Joint Policy Committee, Societies of Epidemiology. Influence of the HIPAA Privacy Rule on health research. JAMA. 2007 Nov 14;298(18):2164-2170.
- Pronovost P, Needham D, Berenholtz S, et al. An intervention to decrease catheter-related bloodstream infections in the ICU. N Engl J Med. 2006 Dec 28;355(26):2725-2732. Erratum in: N Engl J Med. 2007 Jun 21;356(25):2660.