Human Research. Vaughn Chapter 6. Human Research Only a Utilitarian Could Love?. Nazi experimentation on prisoners and civilians US Public Health Service study of syphilis using poor black men from Macon County, AL
Vaughn Chapter 6
Negative public reaction to these events, and others, produced:
Clinical Trial = “[a] scientific study designed to test a medical intervention in humans ...” –Vaughn, 194
Clinical trials …
Vaughn mentions 3 virtues of clinical trials:
What kinds of value to 1 - 3 have?
Blinding = keeping experimental and control group membership secret
Beneficence = doing good for others
in the context of medical science (treatment of patients and test subjects),
Science = in Vaughn, science is presented as in occasional conflict with the duties of beneficence and non-malfeasance
Question: why present the conflict this way, rather than between duties to present and future patients?
Beneficence vs. ‘Science’
“… conflict with the aim of doing science.” -para2, p197
“… treated merely as a means to the end of scientific knowledge.” –para3, p197
“ … beneficence and science collide.” –last paragraph, p198
Is it really some abstract love of science researchers are pursuing when researching drugs and procedures?
What is it they’re doing, if not that?
The main question of this section (Beneficence, Science, and Placebos), is …
How can a physician recommend a patient for clinical trials over prescribing the best known treatment?
“As a physician, she has an obligation to act in the best interests of her patients, which requires that she offer to them only those treatments she judges to be the best. But in clinical trials, patients are randomized into experimental and control groups where they may not receive the treatment that the physician believes is best.” – para1, p198
Reply to problem:
Physicians can recommend participation in clinical trials because they don’t know which treatment is better; they are in a state of equipoise (“rationally balanced between the alternatives” –para2, p198), and so cannot be recommending a treatment they know to be inferior
Defense of problem:
Physicians owe their patients their best judgment, and if there is just a hunch that a standard treatment is better than a new one, physicians cannot recommend, they are not in a state of equipoise
Reply to Defense:
Equipoise is not subjective … it is the state of scientific knowledge where the relative merits of 2 or more treatments is unknown. When those are unknown, including patients in randomized trials is permissible
So, is there any conflict between 1, physicians revealing their honest treatment preferences and 2, offering patients a chance to participate in clinical trials? –para2, p198
Vaughn suggests that as long as full disclosure is met and informed consent is gained, the answer is ‘no’.
Placebos raise another problem:
“Can the deliberate nontreatment of patients be justified?” –para1, p199
The book says ‘Yes’, conditionally:
Vaughn provides a checklist (from CIOMS and WHO) of what research scientists owe clinical trial participants (see p200-201)
Main worries about the possibility of getting meaningful informed consent:
You should know Vaughn’s responses to these objections (1 & 3 … he gives no reply to 2)
Problematic special cases involve clinical trials that involve those who cannot give informed consent and are at the mercy of others:
To take children for example, Vaughn tells us many effective therapies that help children could only be developed by studies on children (as their physiology and pathologies differ substantially from adults)
According to Vaughn, “most official policies” follow these guidelines:
“[t]he child’s refusal to participate in research must always be respected unless according to the research protocol the child would receive therapy for which there is no medically acceptable alternative.” –p203, (Vaughn cites CIOMS and WHO)
The previous slide is about the justification of therapeutic research on children.
See Vaughn’s discussion on p203 … as risk to the research subject goes up, so do requirements for …
The guidelines for treatment of the mentally disabled are similar as those for children, but with special concern for susceptibility to exploitation:
Vulnerable subjects in Third World countries …
Vaughn provides this scenario:
Compare Marcia Angell’s condemnation of these trials to Baruch Brody’s defense of them (p204-205); who is right?