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Case: Use Of A Placebo Control
In 2002 a report was published in JAMA describing the results of a trial of seratraline (Zoloft) versus hypericum (St John's Wort) versus placebo in the treatment of severe depression. It was an eight-week trial and all of the subjects were monitored carefully for increased depression or suicidal tendencies at which time they were removed from the trial. Both seratraline and hypericum were no better than placebo. The investigators pointed out that without the placebo group, the conclusion might have been reached that St John's Wort was equally effective as seratraline.
- Was this an ethical trial? If so, why? If not, why not?
- Discuss equipoise in clinical research
- Discuss Geneva Convention and CIOMS guideless for use of placebos
- Discuss whether clinical research, especially randomized clinical trials require a therapeutic obligation to participants
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Chapter 2
Quick Links
Research in Humans
History of Rules About Research in Humans
Definitions
Federal Mandate
Respect for Persons
Beneficence
Justice
Common Rule
IRB Mission
Cases
Bibliography
Chapter 2 Download (PDF)
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