In the weird world of the Office of Human Research Protections (OHRP) the use of a checklist as a tool to improve medical care is the same as the use of testing experimental drugs.
OHRP does have a major responsibility to those who become subjects in a research project. One of their rules is that the participants in the projects have a reasonable awareness of the risks they are undergoing and that the participants agree to participate in the testing. And, it's a good rule when it comes to drugs. But OHRP applies this rule to any alterations in medical care.
We are all well aware of the growing rise in the number of infections caused by poor hospital practices. Michigan tried to do something about the problem. Realizing that doctors and nurses are under tremendous pressures, Michigan thought that the use of a simple five-step checklist might cause medical personnel to be more likely to follow generally accepted practices (such as the use of sterile gowns and gloves or washing one's hands) known to prevent infection.
For the past year that's what's been happening in the ICU of just about every hospital in Michigan. And the results have been spectacular: hundreds of lives and hundreds of millions of dollars saved.
However, the doctors and nurses using these checklists did not get the permission of the patients allowing the use of the checklists. Hence, they violated medical ethics. The checklists were verboten.
Another example of the consequences of a slavish, mindless following of the rules.
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