Brazilian Society of Bioethics issues note with criticism of the Bill on new rules for research with human beings

Notícia publicada em:

  • 4 de Julho de 2017

The Plenary of the Senate approved, on February 15th, Senate Bill # 200/2015 (PLS # 200/2015), aimed to modify the existing rules on research with human beings. Such a stance is contrary to the majority opinion of militancy in favor of the rights of the participants of the studies, since, in practice, it takes the analysis of the projects from the National Commission of Ethics in Research (CONEP) , thus reducing the performance of the National Health Council (CNS) in the area.

In addition, it makes volunteers even more vulnerable, deleting the requirement of the unlimited supply of drugs after-studies – as it happens today, and as it is respected in many countries of the world – turning it to the provision on the public network.

The Bill with the suggested amendments by the senators was approved in a terminative decision (see details at

However, it follows now for the analysis of the Chamber of Deputies – which means the fight continues: the President of the Brazilian Society of Bioethics (SBB), Regina Parizi, calls the activists of this cause to “remain mobilised” to make contact with the members of the respective States, ensuring social control represented by CONEP/CNS in the field of research in Brazil.

One of the channels is the Contact with the Congressman, on the website of the Chamber, at

A little history on PLS # 200/2015
Presented by Senators Ana Amélia (PP-RS); Waldemir Moka (PMDB-MS) and Walter Pinheiro (PT-BA), throughout its course, the Bill has already been submitted to the Committee on Constitution, Justice and Citizenship (CCJC); Commission of Science, Technology, Innovation, Communication and Information Technology (CCT); and the Commission for Social Affairs (CAS).

According to the text currently in process, the Board of Ethical Review of research projects would be the Secretariat of Science, Technology and Strategic Inputs from the Ministry of Health, “another technocratic body, without hearing the opinion of the CNS, CONEP, and organized society” said recently in an interview to the website of SBB the President of CONEP, Jorge Venâncio (


Being a technical national organ, analysis by the Secretariat of Science and Technology do not include, for example, volunteering, central feature of CONEP. In addition, having the participation of the Minister of Health in the group, as today, allows a closer relationship with the Manager of the moment, which is a big plus.

In its original version, the project provided more controversial changes than the current, such as the creation of a “Commission of Independent Review” for the evaluation of research – without, however, specifying who would take part and possible conflicts of interest between members –; different criteria analysis in projects from abroad; and the discontinuance of providing remedies to the volunteers who were not at risk of death or serious injury two years after the end of the studies, among others.

 Regina Parizi, president of the Brazilian Society of Bioethics