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problems with current informed consent

-humans can't rationally assess risk
-don't want to be in charge, really
-language impenetrable
-can't give all risks
-malpractice info deceiving

how did the belmont commission start?


what does the belmont commission do?

core principles: justice, respect, beneficience
defines human research "pool of generalizable knowledge"

what do IRBs do?

ethics review
-not required, but required if you ever want to get an fda-approved drug
-supposed to enforce belmont report rules

who can't consent?

terminally ill people
sometimes pregnant women

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

-different standards
-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 is eligible for expedited review?

-things that don't ID people or put anyone at risk

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.

can parents consent for child research?

only if it's minimal risk or therapeutic

who is included in the term "vulnerable subjects"?

pregnant women and fetuses
mentally ill ppl

why do we keep compensation low?

to avoid exploiting poor people

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)

what's the most common reason research goes to IRBs?

privacy protection

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