WMA Revises The Declaration Of Helsinki
The World Medical Association, the global representative body
for physicians, has finally approved a revised Declaration of
Helsinki governing the ethics of medical research involving human
participants. It is the fifth time that the document, acknowledged
as the cornerstone of research ethics, has been revised since
it was drawn up in 1964.
The revised Declaration, published today, was adopted at the
WMA's annual general assembly in Edinburgh, which ended at the
weekend.
Dr. Delon Human, Secretary General of the WMA, said that because
of significant changes in the field of medical research, it was
essential to revise the ethical guidelines applicable to research.
"The WMA's main objective is to serve and protect our patients,
especially those who are involved in potentially harmful research
projects. At the same time we applaud and encourage the use of
ethical research to find new ways to cure disease".
He said that changes to the Declaration included a change in
structure to more clearly define the additional standards necessary
when research is combined with medical care. New guidelines have
also been included to call for absolute transparency regarding
economic incentives involved in research.
Dr. Human added: "What has easily been the most contentious
issue is the standard of treatment that should be assured to human
participants involved in research projects. The WMA has affirmed
its position that at the conclusion of any research study, every
patient entered into a research project should be assured of the
best proven prophylactic, diagnostic and therapeutic methods identified
by that study".
"The WMA has also been very concerned about the possible
exploitation of so-called "poor" nations for research
by companies from so-called "rich" countries. New guidelines
in the Declaration will now call on researchers to make sure that
there is a reasonable possibility that the local participants
in a study, including their fellow countrymen, would be able to
benefit from the results (whether positive or negative) of such
studies".
The revised Declaration of Helsinki will be distributed to the
World Health Organization, National Bioethics Commissions, Patient
Representative Groups and other relevant stakeholders. The full
text of the revised Declaration of Helsinki is being posted on
the WMA website (www.wma.net).
The full text of the document is available on request.
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