einstein (São Paulo). 01/Jan/2014;12(1):vii-x.

What changes in Research Ethics in Brazil: Resolution no. 466/12 of the National Health Council

DOI: 10.1590/S1679-45082014ED3077

The Resolution no. 196, of October 10, 1996, of the National Health Council (CNS, acronym in Portuguese), ⁽⁾ approves the regulatory guidelines and norms for research involving human beings and constitutes the first national regulatory mark of ethics applied to research. By means of this resolution, the Brazilian system of ethics review was created, composed by the Research Ethics Committees (CEPs, acronym in Portuguese) and the National Research Ethics Commission (CONEP, acronym in Portuguese), also known as the CEP/CONEP System.

After 15 years, the process of review of CNS Resolution no. 196/96 was initiated. This involved public consultation during the period of September 12 to November 10, 2011, which resulted in 1,890 suggestions sent electronically and the presentation of 18 documents sent by mail. These contributions, duly tabulated, were submitted to the analysis of participants of the extraordinary National Meeting of Research Ethics Committees that produced a document and submitted it to the CNS.

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