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BMJ. Oct 14, 2000; 321(7266): 913.
PMCID: PMC1118720

Doctors revise Declaration of Helsinki

The World Medical Association (WMA) has sent out its strongest ever signal to pharmaceutical companies and research organisations around the world that rich populations should not exploit poor populations by testing on them new treatments from which they will never benefit.

The WMA General Assembly, meeting last week in Edinburgh, approved a revised Declaration of Helsinki, which was first drawn up in 1964 and has since become the most widely accepted guidance worldwide on medical research involving human participants.

The new declaration emphasises in much clearer terms than ever before the duty that doctors owe to participants in medical research. It says that freely given informed consent, preferably in writing, should be obtained from all participants and that people who cannot give informed consent should be included in research only under exceptional conditions.

It also specifies that research is justified only if the populations to be studied stand to benefit and that doctors participating in research have an obligation to declare any financial or other potential conflict of interest.

The meeting was particularly concerned about protecting people in poorer countries from being used as research subjects for the benefit of others. It has done that by specifying in the revised declaration that every patient entered into a study should have access to the best treatment identified by the study, after the study is completed.

Furthermore, the revised declaration calls for testing of any new treatment to be done against the best current method, where that exists, and not against a placebo. The implementation of this would mean that people in developing countries would at least get access to the best current treatment if they agreed to take part in research into new treatments.

Dr Anders Milton, chairman of the WMA, said: “Research should not be carried out in countries in development just because it is cheaper and the laws are more lax. The same ethical rules should apply wherever research is being conducted.

“We have strengthened the position of participants in research, where we have made it much clearer than before that the population involved should benefit, studies should be done against the best proven method, and there should be access to the therapy at the end of the study.”

This is the fifth revision of the Declaration of Helsinki, which was first drawn up in response to the atrocities of the second world war, when prisoners of the Nazis were used for experimentation.

The latest changes have resulted from several years' consultation and are aimed at making the document relevant to today's medical practice. 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 revised Declaration of Helsinki will be distributed to the World Health Organization, national bioethics commissions, patients' representatives groups, and other relevant stakeholders.

The full text of the revised Declaration of Helsinki can be found on the WMA's website (www.wma.net).

The WMA also agreed to:

  • Reinforce its guidance to doctors not to take part “in any way” in capital punishment
  • Support informed donor choice in organ transplantation (countries which have adopted an “opt-out” system—whereby people's organs will be used for transplantation if they have not stated otherwise—are urged to ensure this does not diminish informed donor choice)
  • Express concern about prison conditions, which provide the breeding ground for infectious diseases such as tuberculosis and HIV
  • Support the Indian Medical Association in condemning the practice of female feticide and circulate national medical associations with a statement on the issue
  • Issue a public statement making it clear it is improper for pharmacists to be involved in diagnosing and treating illness
FigureFigure
A Jewish prisoner at Dachau is used in an experiment. The Declaration of Helsinki was drawn up to prevent such crimes.

Articles from BMJ : British Medical Journal are provided here courtesy of BMJ Group
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