Chapter 6- Human research

What is a clinical trial?

a scientific study designed to test a medical intervention in humans

What provides the strongest and most trustworthy evidence of a treatment’s impact on human health?

clinical trials

Why can clinical trials derive reliable answers?

because they maximize objectivity, minimize bias, avoid errors

What are the 2 groups of subjects clinical trials test?

experimental group, control group

What is a placebo?

sham treatment

T/F placebo controlled trials are more trustworthy than other clinical trials

true

What is blinding?

procedure that ensures subjects and researchers do not know which interventions the subjects received

What is the difference btw double and single blinding?

double- both subject and researcher unaware, single- subject unaware

What is randomization?

assigning subjects randomly to experimental and control groups

T/F before a drug is recognized as a proven treatment it must involve 3 phases

true

What is phase I?

tests the drug in a few ppl for safety and adverse reactions

Why is phase I considered nontherapeutic?

because it does not test to see if the treatment works

What is phase II?

investigators give drug to larger group of subjects to get a first indication of its effectiveness

What is phase III?

researcher determines if the drug is effective, how it compares to other treatments and how to safely use it

What are the 5 ethical requirements for clinical trials?

subjects must give informed voluntary consent, study must be designed to minimize risks, subjects must be fairly selected, subjects privacy should be protected, research must be reviewed and approved by independent panel before

What are the 3 moral principles that apply to human research?

autonomy, beneficence, justice

How are therapeutic trials justified?

by the potential good to the subjects and to future patients

How are nontherapeutic trials justified?

by significant potential good to society

What is an argument against controlled trials?

treat subjects as a means to an end

What is the rebuttal to the argument against controlled trials?

if the physician is in equipoise then they do no wrong to their patients in clinical trials

T/F it is believed that is is unethical to use placebo trials when effective treatments are already available

true

What circumstances does the WMA condone placebo studies even when proven treatments exist?

medical condition is minor

What are the essential moral conflicts in regards to research on the vulnerable?

duty to shield vulnerable from abuse, aspiration to benefit them through needed research

Would utilitarians agree with clinical trials?

yes if they provide maximum benefit

What is the central problem associated with using race in medical research?

assuming race is genetically determined

T/F race is not a genetically defined feature of populations but culturally, legally and socially

true