Regulatory Focus™ > News Articles > World Medical Association Prepares to Revisit Declaration of Helsinki on Eve of 50th Anniversary

World Medical Association Prepares to Revisit Declaration of Helsinki on Eve of 50th Anniversary

Posted 25 September 2012 | By Alexander Gaffney, RAC 

The World Medical Association (WMA) is in the advanced stages of preparing to revise the Declaration of Helsinki, one of the cornerstones of international medical ethics, it has revealed.

In a statement released in August 2012, WMA said it plans to hold the first in a series of meetings starting in December 2012 in South Africa to see if it is necessary to make changes to the previous 2008 iteration of the declaration.

In a statement, Ramin Parsa-Parsi, chair of the WMA work group charged with revising the document, said the hope is to keep it, "In line with new developments and challenges in biomedical research."

Not a Legal Standard, and Far from Uniform

Though an important landmark for ethical research standards, it is not legally binding for countries, industry or individuals. The US Food and Drug Administration (FDA), for instance, has not signed on to any revision made since 1996 after changes were made to abandon the use of placebo controls in studies where no therapeutic benefit currently exists.

Still, the declaration is often referenced as a benchmark for many other ethical frameworks. Until 2008, FDA required clinical trials conducted in foreign countries on behalf of pending products before the agency to adhere to the 1989 iteration of the declaration. Many other countries reference other versions of the declaration, such as the 1996 version referenced by the European Commission.

Some of the main issues before WMA, reports the Canadian Medical Association Journal (CMAJ), is whether research participation should be incentivized, how to care for research participants injured in trials and the use of placebos in controlled trials.

A 2013 meeting to be held in Tokyo, Japan is already planned, and the entire process is slated to end by the 50th anniversary of the declaration in 2014.

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