Further changes to the draft revision of the WMA’s Declaration of Helsinki on medical research are to be circulated to the Association’s 102 national medical association members, it was decided this week. This is in preparation for further debate and possible adoption of the document at the WMA’s General Assembly in Fortaleza, Brazil in October.
The Declaration was debated at a special stakeholders meeting in Washington DC on Monday when ethical experts and NMA delegates proposed further changes to the draft revisions that had been issued for public consultation earlier this year. The consultation prompted more than 120 submissions from 36 different countries or regions. A WMA workgroup considered these submissions and further comments at Monday’s meeting and decided that a revised document should be sent to NMAs and to the Association’s medical ethics committee for approval in Brazil. If the committee approves the document it will be considered by the full Council of the Association and sent to the Assembly for adoption.
Dr. Mukesh Haikerwal, Chair of the WMA, described Monday’s meeting in Washington as ‘extremely fruitful’.
‘The quality of debate on issues such as risks, burdens and benefits, informed consent and the use of placebo was of the highest order and as a result we have been able to finalise our draft document.
‘The Declaration is a document of seminal importance to patients, to physicians and to medical researchers throughout the world. Since its inception in 1964 the Declaration has guided the way physicians work and the way that ethics are protected. It has become the cornerstone of contemporary research ethics for physicians, governments and industry in this area of advice on doing medical research on human subjects. And adherence to its principles is critical to preserving the trust of those who are subjects, our patients – and those who conduct research.’
The draft changes to the Declaration incorporate increased protection for vulnerable groups and a strengthening of explicit ethical requirements for placebo use when a known effective treatment is available.