(2001; 76 pages)
Declaration of Helsinki and placebo-controlled clinical trials
The Declaration of Helsinki is acknowledged as the cornerstone of research ethics. Its current guidelines on the ethical use of placebo-controlled trials has caused some confusion in the research world and for this reason the Council of the World Medical Association has decided to publish a note of clarification on their interpretation. This step was necessitated by the cancellation of the Fifty-third World Medical Association General Assembly, which was due to take place during October 2001. The Assembly is the only body with the authority to adopt formal changes to the Declaration. The full text of the note reads as follows.
The WMA is concerned that paragraph 29 of the revised Declaration of Helsinki (October 2000) has led to diverse interpretations and possible confusion. It thereby affirms 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 therapeutical methods, or
• Where a prophylactic, diagnostic or therapeutical 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.
At the same meeting, the WMA decided to appoint a panel of advisers, representative of all stakeholders in research, to assist the WMA in its continuing review of the Declaration of Helsinki.