Page 237 - Pagetit

NEUROSCIENCE OF PSYCHOACTIVE SUBSTANCE USE AND DEPENDENCE

Note of clarification on Paragraph 29
The WMA hereby reaffirms its position that extreme care must be taken in making
use of a placebo-controlled trial and that in general this methodology should only
be used in the absence of existing proven therapy. However, a placebo-controlled
trial may be ethically acceptable, even if proven therapy is available, under the
following circumstances:
— Where for compelling and scientifically sound methodological reasons its use
is necessary to determine the efficacy or safety of a prophylactic, diagnostic
or therapeutic method; or
— Where a prophylactic, diagnostic or therapeutic method is being investigated
for a minor condition and the patients who receive placebo will not be subject
to any additional risk of serious or irreversible harm.
All other provisions of the Declaration of Helsinki must be adhered to, especially
the need for appropriate ethical and scientific review.
1 The Declaration of Helsinki is an official policy document of the World Medical Association,
the global representative body for physicians. It was first adopted in 1964 (Helsinki, Finland)
and revised in 1975 (Tokyo, Japan), 1983 (Venice, Italy), 1989 (Hong Kong), 1996
(Sommerset-West, South Africa) and 2000 (Edinburgh, Scotland). Note of clarification on
Paragraph 29 added by the WMA General Assembly, Washington, 2002.
Source: World Medical Association, 2002 (available on web site http://www.wma.net/e/
policy17-e_e.html).

Principles of biomedical ethics
i. Respect for autonomy
Respecting autonomy means that people respect and do not interfere with
the actions of rational persons that have a capacity for autonomous action,
that is, adults who are able to freely decide upon a course of action without
influence, coercion or force (Beauchamp & Childress, 2001). In the context
of biomedical research, the principle of respect for autonomy is usually taken
to require the following: informed consent to treatment or research
participation, voluntariness in research participation, and maintenance of
confidentiality and privacy of information provided to a researcher
(Beauchamp & Childress, 2001).

ii. Non-maleficence
The principle of non-maleficence simply means, do no harm (Beauchamp
& Childress, 2001). Following the principle of non-maleficence requires
people to refrain from causing harm or injury, or from placing others at risk
of harm or injury. In the context of biomedical research, the principle of non-

216

Chapter_7 216 19.1.2004, 11:50