Who said that?
"Only when there is no known effective treatment is it ethical to compare a potential new treatment with a placebo. When effective treatment exists, a placebo may not be used. Instead, subjects in the control group of the study must receive the best known treatment. Investigators are responsible for all subjects enrolled in a trial, not just some of them, and the goals of the research are always secondary to the well-being of the participants."
Angell
What is the main difference between a physician and a scientist in regard to RCTs?
- Physicians aim to improve individual patient health
- scientists aim to discover new knowledge for the better of the community
Explain Brody’s understanding of coercion
Brody suggests that coercion is defined by the def of coercion involving a threat to put someone below their baseline unless they cooperate, in the case of developing countries, people were given opportunities, the participants wanted the opportunities and were aware of what they were agreeing to.
According to Royall, there are two types of RCTs. What are they?
Experimental Trials and Demonstration Trials
Angell believes a placebo treatment is ethical if there is no known effective treatment, and non-ethical if there is.
True
“The randomized clinical trial requires doctors to act simultaneously as physicians and as scientists. This puts them in a difficult and sometimes untenable position.”
Hellman & Hellman
When a healthcare provider (or a community of providers) is uncertain about the efficacy of treatment
clinical equipoise
How did Brody explain normative and descriptive standards?
Normative standards are what the patients should have received if they were not in a trial and descriptive standards are what they would have received if they were not in the trial
A physician is morally obligated to do what they think is in a patient’s best _______ interest.
medical
A demonstrational trial changes with data to limit harm to patients but still encourages learning.
False, Adaptive Trial
"No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur, except, perhaps, in those experiments where the experimental physicians also serve as subjects."
Nuremberg Code
Randomized Controlled Trials: RCT stands for...
“real” Informed Consent - takes the overarching ideas of substantial understanding, substantial absence of control by others, intentional decision, authorizes a professional to make an intervention (whether that be a test, surgery, procedure, treatment)
Explain the epistemological argument concerning the practical argument for demonstration trials.
The practical argument supporting demonstration trials emphasizes the benefits of the trials and strives to show that the benefits outweigh the costs. That said, the epistemological argument holds that there are no costs to conducting a demonstration trial.
Brody argues that treatment in third-world countries is ethical because it doesn't violate what 3 things?
Justice, coercion, and exploitation
Clicking I accept on the terms and conditions to a long, online privacy policy you didn't read/understand is consent in the 2nd sense.
False, 1st sense
“A multicenter observational study might have been done in which patients at centers such as the University of Michigan, where ECMO was favored, would be compared to the patients at centers such as Johns Hopkins where only “conventional” therapy was available.”
Royall
What are the ingredients of an RCT?
1. a control group, 2. an experimental group, 3. randomization, 4. double blind design, 5. significance test
What was Hellman & Hellman's argument regarding a physician's obligations and its correlation to RCT and permissibility?
A physician is morally obligated to do what they think is in a patients best interest, enrolling a patient in an RCT is not in the patients best interest, therefore enrolling a patient in a RCT is not permissible
Angell believes which of these to come first: the well-being of the patient or the goals of the research
the well-being of the patient
According or Angell’s passage in "The Ethics of Clinical Research in the Third World," when an effective treatment exists, a placebo may be used
False
“Legitimate concerns about exploiting subjects should be addressed by ensuring their future treatment, rather than by asking what will happen in their community at large.”
Brody
Real informed consent takes place when...
hint: (this is sense 1 of consent)
1. substantial understanding
2. substantial absence of control by others
3. intentional decision
4. authorizes a professional to do the intervention (e.g., surgery, test, etc.)
How might Angell’s argument be laid out in an “if then” form?
If a trial is ethical, then the wellbeing of all participants is prioritized over the research goals
If a trial has a placebo control, patient well-being is prioritized over research only if there is no known effective treatment
Therefore, a clinical trial with a placebo is ethical only if there is no known effective treatment
Randomization in RCTs is important because _____.
it gets rid of selection bias and balances the treatment group with respect to covariates
The Hellmans’ side against the utilitarian argument is that we should weigh the ethical cost of clinical trials against the social gain of what we learn from them. What argument are they talking about?
True