In the January 3 issue of Lancet, Charles Weijer, Eric Meslin, and I briefly lay out reasons why FDA's action is regrettable, and how GCP and Helsinki differ. We urge the incoming administration to review this policy, and for medical societies to take action now and endorse Helsinki. Our comment is featured, and is thus accessible for free at Lancet. (photo credit: Vilhelm Sjostrom, "Happy New Year 2009 from Helsinki, Finland," last seconds of 2008)
Tuesday, January 6, 2009
What Will the New Year Bring?
My hope is that, with a new Presidential administration, certain research and ethics policies of the U.S. government might be revisited. One such policy is the FDA's replacement of the Declaration of Helsinki with the International Conference on Harmonization's Guideline for Good Clinical Practice (GCP) for foreign studies. Recall that, in May, I lamented what at that time was a proposed policy change (it was finalized on October 27, 2008).