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OBJECTIVES: To explore attitudes surrounding exception from informed consent enrollment into research studies. In addition, the authors sought to determine the level of awareness of such an ongoing study among potential subjects, as [defined by their presence in an emergency department (ED). Exception from informed consent enrollment in emergency medical research: attitudes and awareness.
METHODS: A convenience sample of urban academic ED patients and visitors was surveyed during a visit regarding their attitudes and awareness of an emergency exception from informed consent, blood-substitute trial ongoing in the community.
1. The voluntary consent of the human subject is absolutely essential.
Is it ethical for individuals to actively seek ways to gain the complicity of lesser educated and contextually ignorant individuals regarding the withholding of information as pertaining to the use of their bodies?
Originally posted by skeptic1
But, then again, personal responsibility shouldn't be negotiable, either. Don't sign something without reading it. Don't agree to something without getting all the facts.
The statistics: There was a significantly higher death rate for people who got the blood substitute than for those who didn’t.
The results come as the Portland area soon will be part of another national medical study that, like the recent study of the artificial blood substitute called PolyHeme, is unusual for what it doesn’t do: It doesn’t inform people they will be part of the study.
Originally posted by americandingbat
The peculiarity of these cases that is allowing for research without informed consent is that the studies are of emergency medical treatments -- the patients are presumably either unconscious or simply not capable of making an informed decision at that time.
BTW, I'm not reading that abstract as looking for ways around informed consent,
These differences may guide institutional review boards and investigators in community-consultation strategies for future waiver of or exception from informed consent studies.