As Revised Declaration of Helsinki Advances, Industry Left Waiting to See Changes

The World Medical Association (WMA) has announced that its planned revisions to the Declaration of Helsinki, one of the most widely recognized ethical frameworks for the conduct of clinical studies, continues to move forward, with the most recent revision released to national medical associations-but not other stakeholders-as of 28 August 2013.

Background

The Declaration of Helsinki was first adopted by the WMA during its Helsinki meeting in June 1964, and has since been amended eight additional times. Its most current revision, if formally adopted, would mark its tenth, and its fifth since the year 2000.

The document is known to be a major cornerstone of many countries' ethical frameworks for the governance of clinical trials.

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.

The WMA has been working on the draft document for months with an end goal of publication by 2014-the 50^th anniversary of the initial declaration.

The Black Box of Helsinki

While initial revisions were first released publicly in April 2013, the WMA's members have been at work behind the scenes revising the update. At the organization's most recent meeting on 28 August 2013 in Washington, DC, the group agreed to circulate those changes to its 102 national medical association members.

In a statement, WMA said the final document would be debated-and possibly adopted-by WMA's General Assembly in October 2013.

One thing the public isn't likely to see before then: a copy of the proposed changes.

When reached for comment, WMA spokesman Nigel Duncan said he was unable to circulate the latest draft, explaining "it was decided at the end of the Washington meeting not to release the revised draft." Duncan added that he had not himself seen the draft, but did not expect it to be available until the Brazil meeting.

Which raises the question:  How is industry-which runs a large percentage of all global clinical trials-supposed to know what's in the WMA draft before it's published?

While WMA's earlier draft included discussion of a number of controversial points, WMA's latest press statement indicates that topics that touched on "risks, burdens and benefits, informed consent and the use of placebo was of the highest order," implying that these sections have undergone further revisions.

"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," WMA explained.

For now, industry will need to wait until October 2013 to see the proposed changes.

WMA Statement