WMA reaffirms Primacy of Patients in Medical Research

A revised version of the Declaration of Helsinki, which sets out ethical principles for medical research involving human subjects, has been adopted by the World Medical Association.

Refusing to bow to pressure from industry and government regulatory agencies, the WMA, at its annual General Assembly in Seoul, South Korea, reaffirmed its controversial stand against practices that open the door to exploitation of research subjects, particularly in developing countries.

On the practice of comparing new experimental treatments to placebos rather than existing treatments, the revised Declaration specifies that this may be done only in very limited circumstances where patients who are given placebos will not suffer any serious or irreversible harm.

The revised Declaration also reaffirms the right of research subjects to share in any benefits that might result from the research, for example, access to interventions identified as beneficial in the study.

New paragraphs of the revised Declaration deal with consent for research on human material, such as blood, tissues, and DNA, and human data and require clinical trials to be registered in a publicly accessible database.

The revised Declaration is the product of extensive consultation with national medical associations, researchers, governments and industry.

Dr. Eva Bågenholm, who chaired the five-country working group that wrote the draft revision, said the consultation showed that the strict provisions of the Declaration for protecting research subjects were sound and firm.

'The WMA now looks to other stakeholders, especially governments, to raise their standards to the Declaration's level', she added.