problems with current informed consent
-humans can't rationally assess risk
-don't want to be in charge, really
-can't give all risks
-malpractice info deceiving
what does the belmont commission do?
core principles: justice, respect, beneficience
defines human research "pool of generalizable knowledge"
what do IRBs do?
-not required, but required if you ever want to get an fda-approved drug
-supposed to enforce belmont report rules
what did the nuremberg code articulate?
was supposed to be a really huge code of ethics; said that "extensive panel research must be conducted before human research"
problem with IRBS
-can be for profit
-overburdensome rules on when to have an IRB (too broad--technically observing public behavior should req. an irb)
-can be too lax (basically just rubber stamps)
-may encourage ppl to study drugs in treatment-naive problems
-easy to recruit either angry people or eagr people--how to find ppl that don't give a poo?
-people don't know anything about specific topic
-geography-based, not study-based
did the nuremberg code affect medicine?
yes; shifted focus onto poorer people nd making sure that no individual loses rights (?)
what does minimal risk mean?
no more than faced in an ordinary day or doctor's visit (blood draw, blood pressure gauge)
problems with "minimal risk"
ppl have different levels of minimal risk. does this mean if we use all poor cocaine addicts we can do whatever we want to them? what about the grimes lead case?
-no average, objective risk
what is the therapeutic misconception?
research in human subjects is seen as access to cutting edge meds, but REMEMBER THAT some people get placebos and also they're experiments. people die.
who is included in the term "vulnerable subjects"?
pregnant women and fetuses
mentally ill ppl
(NOT POOR PEOPLE AND MINORITIES)
does outsourcing research to international, treatment-naive communities go with the belmont rules?
NO. no justice.(although they're still getting benefits from the research in financial terms)