Basic
standard treatment (standard vs. new version)
What is active control
"ONLY WHEN there is no effective treamtment us ut ethical to compare a potential new treatment w/ a placebo."
Who is Marica Angell
assigning a patient to a placebo may result in less good care
what is Hellman & Hellman's belief
"real" informed consent
(surgery)
What is sense 1
Royall argues that this feature of RCTs helps eliminate bias between treatment groups.
What is randomization?
compares a new treatment against an inactive substance
What is placebo control
Would they have had access to treatment otherwise
What is Brody's understanding of injustice
-particular physician
-more exact sense of uncertainty
What is Hellman and Hellman's idea of quipoise
Whatever the law requires
(terms and conditions)
What is sense 2
Royall distinguishes between trials that generate new knowledge and those that simply show a treatment works in practice.
What are experimental vs demonstration trials?
-control group
-experimental group
-randomization
-double-blind design
-significance test
What is parts of an RCT
Individuals not receiving their fair share
Hellman and Hellman argue that randomized clinical trials put physicians in this conflicting dual role, creating ethical tension.
What is being both a physician and a scientist?
Who worries that sense 2 doesn't get you sense 1
Who is Faden and Beauchamp
Royall supports RCTs partly because they help ensure this between groups, making comparisons fair.
What is comparability (or reducing bias between groups)?
When a healthcare provider is uncertain about the efficacy of treament
What is clinical equipoise
There is a threat to reduce below the baseline
What is Brody's understanding of coercion
What group of people are Hellman & Hellman responding to:
"Rather [individuals] must be always treated as ends in themselves."
Who are Utilitarians
-how deadly is the disease
-are there other treatments available
What are ethical considerations
This is Royall’s key idea that RCTs provide strong justification for believing one treatment is better than another.
What is the epistemological argument?
Increased laws for grave robbing
What is Anatomy Acts
Who believes that RTCs in third world countries are not unethical
Who is Baruch Brody
This objection claims that randomized clinical trials are justified because patients agree to participate, but the Hellmans argue patients cannot fully waive certain rights.
What is the autonomy objection?
experiment where 600 low-income African American men with syphilis were observed, denied treatment, and deceived to study the disease's natural progression.
What are the Tuskegee Trails
Royall uses this concept to determine when it is acceptable to randomize patients in a trial.
What is equipoise (or clinical equipoise)?