Public Consultation opens on WMA Helsinki Declaration

A two-month public consultation on the World Medical Association’s Declaration of Helsinki on medical research involving human subjects began today (Monday) with the posting of a revised version of the Declaration on the WMA website.

The public and the WMA’s 102 national medical association members are being invited to comment on the proposed changes which have been drawn up following an 18-month process of deliberation. A WMA workgroup has held comprehensive discussions and three expert conferences to help it draft the changes.

In an explanatory note on the WMA website, the workgroup 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.

For details of the major changes, people should refer to the WMA website.

All experts and stakeholders have been invited to submit comments to the WMA secretariat no later than 15 June 2013.

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.