NATIONAL HEALTH COUNCIL


RESOLUTION #301, 16th March 2002


The Plenary Assembly of the National Health Council , in its 95th Ordinary Meeting, ocurred  on  15-16  March  2002,  
in  the  use  of  its  regimental  competencies  and  granted attributions by the Law n# 8.080, of 19 November 1990 and 
by the Law n# 8.142, of 28 December 1990, considering,
▪    the responsability of the National Health Council in protecting the integrity of the research   subject,   having  
 constituted   the   National   Committee   of   Ethics   in Research – CONEP (in Portuguese);
▪    the    directives  and  adjustment  rules  of  Research  involving  Human  Beings, Resolutions CNS 196/96, 251/87 
and 292/99;
▪    the  discussion  of  proposals  to  modify  the  Declaration  of  Helsinki,  ruled  by  the General   Assembly   
of   the   World   Medical   Association,   to   take   place   in October/2000 in Edinburgh;
▪    the  representatives  of   the  Brazilian  Medical  Association  in  the  mentioned Assembly

DECIDES:

1 – To keep inalterable the item II.3 of the mentioned Declaration: “In any medical study, every patient – including 
those of a control group, if any – should be assured of the best proven diagnostic and therapeutic method.”
2 – To express contrarily to the proposed altarations, especially the one referring to the  use  of  placebo  in  the  
face  of  the  existence  of    therapeutic  and  diagnostic methods proved.
3  –  Urge  with  the  Brazilian  Medical  Association  to  send  this  position  to  the organizers of  the General 
Assembly of  the World medical Association as soon as possible.




JOSÉ SERRA
President of the Nacional Health Council


I ratify the Resolution CNS n# 301, of 16 March 2000, in the terms of the Competency Delegation Decree of 12 November 
1991

JOSÉ SERRA
Minister of Health