Declaration of Helsinki and FDA

The newly released Declaration of Helsinki was issued by the 59th World Medical Association General Assembly in October 2008. This document details ethical principles for medical research involving human subjects.

Section 19 requiring every clinical trial to be registered before recruitment of the first subject. Also note Section 30 on the obligation to make public the results of research on human subjects and requirements for publications. The additional contents are in line with the recent push for registry of the clinical studies and publication of the clinical trial results.

http://www.wma.net/e/policy/pdf/17c.pdf
http://www.wma.net/e/index.htm
http://en.wikipedia.org/wiki/Declaration_of_Helsinki

However, the FDA is moving away form the Helsinki accords because of what it says about placebo. The following two links discussed this issue.
http://www.socialmedicine.org/2008/06/01/ethics/fda-abandons-declaration-of-helsinki-for-international-clinical-trials/
In 21 CFR 312, "Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application- Notice of Final Rule", FDA states
" The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the Declaration of Helsinki (Declaration) issued by the World Medical
Association (WMA), specifically the 1989 version (1989 Declaration), with a requirement that the studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC)."

A article on EMBO report (7(7), 2006) titled "The Battle of Helsinki" is worth to read.

North Carolina's Triangle Business Journal (2/19, Gallagher) reports that "the study also questions the decision by the US Food and Drug Administration in 2008 to abandon the Declaration of Helsinki, a set of standards adopted by the World Medical Association in 1984 that required trials to compare new drugs with the most effective alternative." The Food and Drug Administration "dropped the Helsinki standards in favor of the policy of Good Clinical Practice adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. That policy, which allows drug manufacturers to compare the results of the new drug with those of a placebo, is considered by some to be less stringent than the Declaration of Helsinki."