WMA to Continue Discussion on Declaration of Helsinki

Sharp differences of opinion over how to protect human participants in medical research and avoid exploitation of vulnerable populations emerged at the World Medical Association’s General Assembly meeting in Helsinki this weekend.

Physician representatives from more than 40 countries were debating whether to amend the Declaration of Helsinki that seeks to protect people involved in medical research. At issue was a controversial provision in the document, as revised in 2000, about the extent to which patients involved in research studies should be given the best available treatment at the end of a study.

Critics of the revised Declaration claim that, as currently worded, its provisions on making the best proven care available are unrealistic and would prevent much research from being undertaken.

Delegates at the WMA’s meeting heard a succession of speeches from physician representatives, invited ethicists, philosophers and other experts about how to resolve the dilemma. The Assembly finally decided to set up another working group to consider the conflicting views both from within the medical profession and from outside and to report back to the WMA Council next May.

Dr Yoram Blachar, chairman of the WMA Council, said:

“There are clear differences of position at the moment about how we should move forward – whether we should amend the Declaration or seek to clarify its present wording or just leave things as they are.

At the moment we have decided to make no changes and to issue no clarification, but to carry on discussing this issue.

We are all agreed that the world’s most vulnerable patients must be protected in research trials. The only question is how best we can achieve that. That is what we shall continue to discuss”.

* Members of the new working group are:

  • Sir David Carter (UK)
  • Dr Dirceu Greco (Brazil)
  • Dr Ottmar Kloiber(Germany)
  • Dr Kgosi Letlape (South Africa)
  • Dr John Nelson (USA)