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Lecture 13

PHLB09H3 Lecture Notes - Lecture 13: Informed Consent, Kantianism, Ethical Dilemma

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Anthony Bruno

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Chapter 6 Human Research
Medical research on humans
Two dues:
Two consequences:
-Abuse ( untreated, undisclosed, infected, experimented)
Clinical trials
-test medical treatment
-determines safety/e$ecveness
-max objecvity
-Avoiding error
Subject groups:
-treatment main factor in change?
1. Placebo control group
–placebo e$ect
–greater improvement in experimental subjects?
2. Acve control group
- Proven treatment
- New outperforms proven treatment
-Ignorance (placebo, new, old)
-assigning subjects to groups
Benecence, science and placebos
Morally permissible clinical trial:
-low risk
-Fair subject selecon
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-Approved research
Balance of B w/ A&J
Con8ict b/w A&B:
-subjects as means to inquiry
-Control group receives possibly inferior or no treatment
-subjects can be useful and respected
-doctors secondary duty is as researcher
Two more disputes:
1. Sacrice paent interest for study
- Fine if no evidence for preference
2. Doctors owe preference--- equipoise is wrong
- Equipoise: suspending judgement on merits of di$erent treatments due to
inconclusive evidence
Moral concern about placebo
- No real treatment
- Wrong if e$ecve treatment available
- Wrong if illness fatal
Science and Informed consent
IC moral prerequisite for CT
Obstacles to IC:
-serious illness
-No available treatment
Research on the vulnerable
CT for children:
-unique physiology, pathology
-policies require assent (not IC)
-Permissible if benecial
-permissible if no benet yet no alternave/yields knowledge
CT in developing countries:
Claim: placebo control group endangered
Response: subjects not denied an available treatment
Applying major theories
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