Ethics in medical research and the essential bureaucracy of ethics committees: an experience report

Since October 1996, Brazil has a new regulation on research involving human beings, it is the Resolution nº 196 of 1996 of the National Health Council, instance in which the National Research Ethics Commission and the Ethics Committees were created in Research – EC. This resolution says that each and every research project, in any area, involving human beings must contain an analysis of ethical aspects – carried out by the researcher himself – and be approved by the Research Ethics Committee. Research involving human beings is understood to be that which, individually or collectively, directly or indirectly involves human beings, in their entirety or parts of them. This article reports the difficulties in developing a research project that will later be approved by an EC, but with an emphasis on why these difficulties exist