Academic Horror Story (Johns Hopkins University)

I previously blogged about ICU checklists. Atul Gawande has written another excellent article about them, this time an editorial in the New York Times:

A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.

The results were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.

Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.

The government’s decision was bizarre and dangerous. But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. . . . A checklist may require even more stringent oversight [than drug tests], the [OHRP] ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures. . . .

A large body of evidence gathered in recent years has revealed a profound failure by health-care professionals to follow basic steps proven to stop infection and other major complications. We now know that hundreds of thousands of Americans suffer serious complications or die as a result. It’s not for lack of effort. People in health care work long, hard hours. They are struggling, however, to provide increasingly complex care in the absence of effective systematization.

Excellent clinical care is no longer possible without doctors and nurses routinely using checklists and other organizational strategies and studying their results. There need to be as few barriers to such efforts as possible. Instead, the endeavor itself is treated as the danger. . . . Scientific research regulations had previously exempted efforts to improve medical quality and public health — because they hadn’t been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. And they’re in danger of putting ethics bureaucracy in the way of actual ethical medical care.

Not “in danger of” — they have put “ethics bureaucracy” ahead of patient safety. In a big way.

6 Responses to “Academic Horror Story (Johns Hopkins University)”

  1. sysrick.com » links for 2008-01-01 Says:

    [...] Academic Horror Story (Johns Hopkins University) [...]

  2. Seth’s blog » Blog Archive » Anti-Depressants, Suicide, and a Malfunctioning Legal System Says:

    [...] Academic Horror Story (Johns Hopkins University) [...]

  3. links for 2008-01-04 « Matthew Henty Says:

    [...] Seth’s blog » Blog Archive » Academic Horror Story (Johns Hopkins University) (tags: bureaucracy healthcare ethics) [...]

  4. David Hunter Says:

    Seth I don’t see the problem here.

    Why did John Hopkins not simply apply for approval before they began what was clearly research?

    You seem to be siding with Hopkins because it worked, but what if it hadn’t? What if their experiments had negative effects, would you then be condemning them? The job of research ethics committees is to ensure research is carried out ethically, and I don’t see how bypassing them is laudable.

  5. Royce Fessenden Says:

    I’m stunned at David Hunter’s comment that elevates an administrative procedure to the same level as “medical research”. This is the same type of medieval madness that objected to doctors washing their hands and cleaning up the bloody surgeons gowns.

    Who will protect us from the “ethics” protectors!

  6. PJ Eby Says:

    FYI, a response from the OHRP is here:

    http://www.hhs.gov/ohrp/news/recentnews.html#20080115

    They seem to be saying that as long as you’re not *researching* whether checklists actually WORK, it’s okay to just go ahead and USE them. Which seems a bit weird, but oh well.