CAS PH 251 Lecture Notes - Lecture 8: False Dilemma, Design Of Experiments, Syphilis
7 Aug 2018
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Topic 2: Biomedical Research Ethics
Therapy vs. Research: A False Dichotomy?
● Therapy = biomedical interventions that are designed solely to
benefit an individual or group of individuals.
● Research = scientific experiments/data gathering, which may
include biomedical interventions, intended to lead to generalizable
knowledge.
o Clinical Research = subjects suffer from some illness or
susceptibility that the experiment aims to develop methods to
treat.
o Non-clinical research = subjects do not directly benefit
from the experiment.
● Ask: Who benefits from research and who incurs the costs
Why Experiment on human beings?
● Why not simply
o (1) run computer simulations,
o (2) work with cultures of cells,
o (3) experiment only on non-human animals?
● Benefits of Controlled Experiments
● Evidence-Based Medicine
Ethical Conditions for Human Research Protocols
● Must be of social or scientific value
● Experimental design must be methodologically valid
● Subjects must be selected fairly
● The risk-benefit ratio must be favourable
● There must be independent ethical review
● Must obtain informed consent of subjects
● Subjects must be treated respectfully
The Numberg Code (1947)
● WWII Background
● Nazi Medical Experiments
● http://www.ushmm.org/wlc/en/gallery_ph.php?ModuleId=1000516
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● Imperial Japanese Medical Experiments
● Some highlights:
o Informed Consent (Point 1)
Document Summary
Therapy = biomedical interventions that are designed solely to benefit an individual or group of individuals. Ask: who benefits from research and who incurs the costs. Declaration of helsinki : ethical principles for medical research. Declaration of helsinki= statement of ethical principles to provide guidance to physicians and participants in medical research involving human subjects. Must be of social or scientific value. Placebo = fake medical intervention: placebo effect = the healing response that"s triggered when people merely think they"re being medically treated. Causal explanations of placebo (an evolutionary narrative) Two competing views (as per emanuel and miller): Placebo orthodoxy = placebo-controlled studies are ethical, even if there is an existing effective treatment, so long as withholding an effective treatment won"t be life threatening or result in serious, irreversible injury to subjects in the placebo group. Active control orthodoxy = if there"s an effective treatment available, then the use of placebo is categorically unethical (helsinki.
