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On Medical Research Bureaucracy and the Institutional Review Board


I read this story about a doctor trying to get permission to do a harmless research study by giving people a simple questionnaire, and the loopholes he eventually gave up trying to jump through.

I have had some limited experience with big government bureaucracies, and his conclusion here really mirrors my thoughts:

I sometimes worry that people misunderstand the case against bureaucracy. People imagine it’s Big Business complaining about the regulations preventing them from steamrolling over everyone else. That hasn’t been my experience. Big Business – heck, Big Anything – loves bureaucracy. They can hire a team of clerks and secretaries and middle managers to fill out all the necessary forms, and the rest of the company can be on their merry way. It’s everyone else who suffers. The amateurs, the entrepreneurs, the hobbyists, the people doing something as a labor of love. Wal-Mart is going to keep selling groceries no matter how much paperwork and inspections it takes; the poor immigrant family with the backyard vegetable garden might not.

Bureaucracy in science does the same thing: limit the field to big institutional actors with vested interests. No amount of hassle is going to prevent the Pfizer-Merck-Novartis Corporation from doing whatever study will raise their bottom line. But enough hassle will prevent a random psychiatrist at a small community hospital from pursuing his pet theory about bipolar diagnosis. The more hurdles we put up, the more the scientific conversation skews in favor of Pfizer-Merck-Novartis.

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A good read.
Another quote:

this is happening at the same time we’re becoming increasingly aware of the shortcomings of big-name research. Half of psychology studies fail replication; my own field of psychiatry is even worse. And citizen-scientists and science bloggers are playing a big part in debunking bad research: here I’m thinking especially of statistics bloggers like Andrew Gelman and Daniel Lakens, but there are all sorts of people in this category. And both Gelman and Lakens are PhDs with institutional affiliations – “citizen science” doesn’t mean random cavemen who don’t understand the field – but they’re both operating outside their day job, trying to contribute a few hours per project instead of a few years. I know many more people like them – smart, highly-qualified, but maybe not going to hire a team of paper-pushers and spend thousands of dollars in fees in order to say what they have to say. Even now these people are doing great work – but I can’t help but feel like more is possible.
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(some links included in that paragraph at source)


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