Ethics of Research with Human

Subjects
 Necessary Fallibility
In studying the nature of medical malpractice and negligence, the
philosophers Samuel Gorovitz and Alasdair MacIntyre coined the term
“necessary fallibility,” a condition of the applied sciences such as
medicine, pharmacy, engineering, and agriculture.
Unlike the theoretical sciences such as physics, chemistry, and biology,
whose aim is to understand universals or kinds of things, the essential
understanding required of the applied sciences is the behavior of
particulars or instances of kinds of things.
 Necessary Fallibility
While the theoretical scientist is interested only in information that
sheds light on the kind itself, the applied scientist is interested in all
information that bears on the behavior of an individual thing. Because
the amount of information bearing on the behavior of an individual
thing requires something approaching omniscience, some degree of
error is practically built in to the practice of the applied sciences.
Hence, necessary fallibility.
 Therapeutic Misconception
Therapeutic misconception is a concept introduced by Appelbaum, Lidz,
and Roth in the 1980s referring to the phenomenon of patients
enrolled in clinical trials being under the mistaken understanding that
every intervention done to them in the course of the trial is done for
their benefit.
 Equipoise
Equipoise is the ethical requirement that investigators be genuinely
ignorant of the truth of the hypothesis they are testing before they are
justified in exposing subjects to risk. The practical problem for
equipoise is that it is very easily disturbed. During the course of a
successful randomized clinical trial it will become evident that the
condition of subjects in one arm of the study is improving. What
justification is there at that point to continue the trial? Equipoise can
be disturbed by so much as a hunch.
 Freedman on Equipoise
In a 1987 paper, bioethicist Benjamin Freedman argued for a solution
to the practical problem for equipoise by distinguishing between two
forms of it.
• Theoretical equipoise is the attitude of the individual investigator.
• Clinical equipoise is the attitude of the research community.
Freedman argues that it is clinical equipoise that is decisive since a
research conjecture is not accepted by the research community until a
study has been successfully completed and validated.