Principles and Practice of Pharmaceutical Medicine

(Elle) #1

Informed consent


As the term implies, subjects must be fully
informed about the nature of the experiment, the
known benefits and risks and the possibilities of
unknown risks to which they will be exposed.
Consent must be givenautonomouslyand obtained
without any coercion – direct, indirect or per-
ceived.
Already, a number of problems are evident.
Fully informing a patient as to the nature of an
experiment and its attendant risks, known and
unknown, is an arduous task. The language used
must lack ambiguity, and understanding must be
real – even for those who cannot fathom the tech-
nical issues.
It has been shown repeatedly that humans
are notoriously bad at assessing personal risk. As
Beecher has suggested,^11 although many patients
arewilling to help their doctors, their fellow humans
and science to improve medical care, most are not
willing to assume significant risk in this endeavor,
and few would be willing to risk serious injury or
death. Yet, such outcomes nonetheless continue to
occur, and analysis of recent disasters has often
centered on whether subjects have fully understood
the nature of their consent, rather than on the actual
clinical procedures being implemented.
Henry Beecher (1904–1976) discussed^12 the key
concepts in human research of consent and auton-
omy, and the inherent difficulties in achieving
these. People in positions of dependency may be
termed ‘vulnerable groups’; these can include min-
ors, prisoners, employees and family members.
Conversely, Beecher established that there is no
duty to participate in clinical research – an example
in which public or societal good cannot outweigh
personal risk.


The primacy of truly informed consent is such
that it deserves its own chapter, elsewhere in this
book.

Clinical equipoise


Benjamin Freedman (1951–1997) defined clinical
equipoise as ‘a state of genuine uncertainty on the
part of the investigator [or–present or imminent
controversy in the clinical community] regarding
the comparative therapeutic merits of each arm in a
trial’. Freedman continued that ‘at the start of the
trial, there must be a state of clinical equipoise
regarding the merits of the regimens to be tested,
and the trial must be designed in such a way as to
make it reasonable to expect that, if it is success-
fully conducted, clinical equipoise will be dis-
turbed’.
Clinical equipoise and informed consent raise
issues of beneficence and nonmaleficence, both of
which may beviolated by participation in the study.
However, if there is intent to do good and to avoid
harm, then arguably these concerns are satisfied.

45.4 Ethics of animal
experimentation

Public disagreement surrounds the use of animals
in research – which occurs primarily to benefit
humans, although some agricultural and veterinar-
ian studies are carried out to benefit animals them-
selves. Three distinct approaches are offered here:

‘Duties Toward Animals’ (Immanuel Kant)^13

‘A Utilitarian View’ (Jeremy Bentham)^14

(^11) Beecher HK. 1966. ‘Ethics and clinical research’.N. Engl.
J. Med. 274 (24): 1354–1360, reprinted in ‘Bioethics: an
Introduction to the History,Methods, and Practice’, Jecker,
Jonsen, Pearlman (eds). Jones and Bartlett Publishers:
Sudbury; 1997.
(^12) Beecher HK. 1966. ‘Ethics and clinical research’.N. Engl.
J. Med. 274 (24): 1354–1360, reprinted in ‘Bioethics: an
Introduction to the History, Methods, and Practice’, Jecker,
Jonsen, Pearlman (eds). Jones and Bartlett Publishers:
Sudbury; 1997.
(^13) Kant I. ‘Duties towards animals’, from ‘Lectures on Ethics’
trans. Louis Infield. Harper and Row: New York; 1963, and
reprinted in ‘Bioethics: an Anthology’, Kuhse, Singer (eds).
Blackwell Publishers: Oxford and Malden; 1999 (written
about 1790).
(^14) Bentham J. First published c. 1820 inAn Introduction to the
Principles of Morals and Legislation, Section XVIII, and
reprinted in ‘Bioethics: an Anthology’, Kuhse, Singer (eds).
Blackwell Publishers: Oxford and Malden; 1999.
45.4 ETHICS OF ANIMAL EXPERIMENTATION 591

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