7 Informed Consent

Anthony W. Fox

7.1 Introduction

There is a tendency to assume that the principles
of informed consent are self-evident. In fact,
evidence that this is not the case comes from
many sources, such as ethics committees that
are frequently dissatisfied with proposed infor-
med consent documents, and sophisticated
Western governments that, from time to time
have conducted clinical trials without it (e.g. the
Tuskeegee travesty). A recent gene therapy acci-
dent in the eastern United States, which led to the
death of the participant, led to litigation which
was centered not around whether the clinical trial
was unduly hazardous but rather on whether the
consent that the patient gave was truly and fully
informed.
Informed consent was first formulated under
international law through the Declaration of
Helsinki, and in response to the atrocities of the
Second World War. The principles of informed
consent are under continuous review and dis-
cussion (e.g. Marsh, 1990). This is to be expected
when reasonable standards of informed consent are
dependent not only on the design of a particular

study but also on environmental factors, the current

state of medicine and particular local characteris-

tics of clinical trials populations, all of which are

themselves continuously changing.

7.2 Ethical basis

Although discussed in detail elsewhere in this

book, the two ethical principles guiding informed

consent are those ofautonomy and equipoise.

Autonomyis the concept that the patient is an

individual that is under no duress, whether subtle

or obvious, actual or inferred, and is competent to

make a choice according to his or her free will.

Clinical trials conducted on persons in custody, or

on subordinate soldiers, may both be violations

of the patient’s autonomy.Equipoiseis the concept

that the investigator, and those sponsoring the

trial, are truly uncertain as to the outcome of the

study; in practical terms, this is a guarantee to

the patient that an unreasonable hazard cannot

result from unfavorable randomization because

the treatment options are not known to be

unequally hazardous.

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9