Recommendations guiding physicians in biomedical research involving
human subjects
The idea for a position paper on this topic was first brought
to the attention of the Medical Ethics Committee in 1953. Undoubtedly,
the member associations requesting the study of this matter, were
inspired in part by the horrors - revealed during the Nuremberg
trials - of physicians engaging in experimentation on human beings
with little or no regard for the welfare of the subjects. Accordingly,
the WMA felt that there was a need to provide physicians all over
the world with recommendations to guide them in biomedical research
involving human subjects. After several years of discussion and
research, a draft Declaration was prepared. This draft, originally
tabled in 1961, was examined and revised several times until its
final adoption at the 18th General Assembly in Helsinki, Finland,
in 1964.
The Declaration remained untouched until 1975, although on several
occasions there were attempts or suggestions to have it revised
in light of the rapid advance of medical technology. It took no
time for the Council to name a special sub-committee composed
of three Scandinavian doctors (Clarence Blomquist, Sweden; Erik
Enger, Norway; Povl Riis, Denmark) to pursue a revision which
would delineate more specifically the ideas and provide more detailed
guidelines. This committee's recommendations were accepted by
the 29th Assembly in Tokyo, Japan, in 1975.
Although the general focus and core ideals remained the same,
the 1975 revisions were extensive: i.e., changing the terminology
throughout, adding 17 new paragraphs, amending several existing
points, and restructuring the document. The result of these changes
was that the list of "Basic Principles" was expanded,
and the following two categories (the first of which deals with
research combined with therapeutic care and the second with research
for purely scientific purposes) were crafted to provide guidelines
more specific to those particular circumstances.
In 1983 all WMA Declarations and Statements were reviewed to
ensure consistency and the use of up-to-date terminology. The
Declaration of Helsinki was revised again although most of the
revisions were strictly editorial in nature. The only substantive
change made was the addition of a clause stating that "when
a child is to be a subject for research, that minor's consent
must be obtained."
In 1989, the German Medical Association expressed concern about
the Declaration's Basic Principle 2 which calls for an experimental
protocol to be transmitted to a "specially appointed independent
committee." The German Medical Association introduced an
amendment to define more clearly the appointment and status of
this committee which was adopted at the Assembly in Hong Kong,
in 1989.
The Declaration was again amended at the 48th Assembly in South
Africa, in 1996. This time the revision represented the addition
of a new sentence in order "not to exclude the use of inert
placebo in studies where no proven diagnostic or therapeutic method
exists.
The Declaration is now undergoing massive new revisions which
will be discussed at the 52nd General Assembly in Edinburgh, Scotland
in 2000.
To close this section on the Declaration of Helsinki it should
be noted that this WMA document has had great impact on human
experimentation and has served as a starter for establishing ethical
committees in various countries to scrutinize research projects
on human beings. It has been adopted not only by WMA member associations
but is also recommended by the World Health Organization, and
referred to by many International Laboratories, Specialty Medical
Societies, the Committee of Ministers of the Council of Europe,
etc.
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