WMA opens public consultation on revisions to Declaration of Helsinki

A two-month public consultation on the World Medical Association’s Declaration of Helsinki on medical research involving human subjects has begun with the posting of a revised version of the Declaration on the WMA website. Stakeholders have been invited to submit comments to the WMA secretariat no later than 15 June 2013.

In an explanatory note on the WMA website, the workgroup leading this revision states that the proposed changes provide for more protection for vulnerable groups and all participants by including the issue of compensation, more precise and specific requirements for post-study arrangements and a more systematic approach to the use of placebos. In addition the workgroup states that the revised text maintains the unique character and length of the Declaration. It also provides better readability by reorganising and restructuring the document with sub headings.

The workgroup will then produce a final revised draft to be considered by the WMA’s ethics committee and Council at their meetings in Fortaleza, Brazil in October 2013 when a decision will be taken whether to forward the document to the WMA Assembly at the same meeting for adoption.