The history of the CEP/Conep System began in 1988 with the publication of CNS Resolution No. 01 of 1988, which established that all institutions carrying out research with human beings should have an “Ethics Committee”. The term “CEP” (Research Ethics Committee) came years later, with CNS Resolution N° 196 of 1996. This same rule determined that an Executive Working Group (previously constituted by CNS Resolution N° 170 of 1995) would It would be through the creation process of the National Commission of Ethics in Research – Conep. The term “CEP/Conep System” appeared sixteen years later, when CNS Resolution No. 466 of 2012 defined it as follows: “It is made up of the National Research Ethics Committee – Conep/CNS/MS of the National Health Council and by the Committees of Ethics in Research – CEP – composing a system that uses mechanisms, tools and instruments of interrelationship, in a cooperative work that aims, especially, at the protection of research participants in Brazil, in a coordinated and decentralized way through a process accreditation”.
The CEP/Conep System aims to protect research participants in their rights and ensure that studies are conducted ethically. The ethics of research necessarily implies:
- Respect the participants in their dignity and autonomy;
- Weigh risks and benefits;
- Avoid or reduce as much as possible damage that is foreseeable;
- Have social relevance;
- Be fair and equitable;
- Don't be futile and;
- Respect the rights of participants.
This manual highlights the so-called “repeat issues”. They correspond to the main ethical issues that Conep has pointed out in its substantiated opinions regarding clinical research protocols, particularly clinical trials with new drugs. There is no intention of exhausting the subject, but only to assist researchers and sponsors in the preparation and submission of protocols on the Brazil Platform. Thus, it is expected to substantially reduce the number of ethical notes made by Conep and, with this, accelerate the
processing of protocols in the System.