Revisiting Helsinki
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* John Hoey
* Anne Marie Todkill

*   © 2004 Canadian Medical Association or its licensors

We agree with Dirceu Greco that the “clarifications” to the Helsinki Declaration proposed by the medical associations of some affluent countries weaken the protection afforded to study subjects, particularly those who are impoverished. The proposed footnotes do not clarify but obfuscate, letting researchers and their sponsors off the hook of their responsibility to ensure the continuing treatment of study subjects upon termination of a clinical trial.

Henry Haddad and the CMA take us to task for accusing them of “silence” on the issue of footnotes to Helsinki.1 We apologize for not being more specific. A working document compiled before the meeting2 contains statements from 8 national associations, but not from the CMA. Haddad, the CMA's delegate at the meeting, did speak at the WMA's Ethics Committee Debate on paragraph 30. Yet the position of the CMA on this important issue remains ambiguous. From a transcript of an audio recording of the debate, forwarded to us by the CMA, we learn that Haddad spoke in support of retaining the “note of clarification” as amended by the American Medical Association, to the effect that sponsors should be “encouraged” (as opposed to required) to ensure access to treatment after the study. However, Haddad suggested the addition of a clause to “suggest that physicians should not partipate in studies where they can't get a guarantee from the sponsor that there would be ongoing treatment after the study.” Which is it?

**John Hoey** **Anne Marie Todkill** *CMAJ*

## References

1.  1. Dismantling the Helsinki Declaration [editorial]. CMAJ 2003;169(10):997. 
    
    [FREE Full Text](http://www.cmaj.ca/lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiRlVMTCI7czoxMToiam91cm5hbENvZGUiO3M6NDoiY21haiI7czo1OiJyZXNpZCI7czoxMDoiMTY5LzEwLzk5NyI7czo0OiJhdG9tIjtzOjIxOiIvY21hai8xNzAvMS8yMi4xLmF0b20iO31zOjg6ImZyYWdtZW50IjtzOjA6IiI7fQ==) 

2.  2. *Comments on the workgroup report on the revision of paragraph 30 of the Declaration of Helsinki* [Document no WG/DoH/Sept2003/COMM]. Helsinki: World Medical Association; 2003 Sept 3.