One of the most visible forms of
contemporary scientific research is the randomized controlled clinical trial.
In its basic structure,
the clinical trial is a form of experimentation
on human subjects that involves administering
a potentially useful experimental therapy or
intervention to some of the subjects in the trial,
while withholding the therapy or intervention from other subjects in the trial.
The latter is usually referred to as the control group.
Subjects are recruited to the study based on predetermined selection criteria.
And after recruitment, the subjects are randomly
assigned to either the experimental or the control group.
Often, the study participants,
and sometimes those carrying out the trial,
are blinded, meaning that they do not know
which subjects are assigned to which group while the study is going on.
Today, this research methodology is often cited
as the goal standard of scientifically rigorous research.
However, because human subjects are involved,
ethical concerns are always present.
By using concrete historical examples,
this lecture will show how these concerns have been dealt with in the past and explain
the underlying ethical principles that should guide
researchers who design clinical trials in the future.