Before starting a human research project, it is mandatory to register the project on SISNEP – National Information System on Human Research Ethics. Registrations is made using the Plataforma Brasil, to which researchers must sign up in order to submit projects, attach information and documentation, follow project evaluation and other measures.

After that, the project will be analyzed by CEPSH and an evaluation will be issued.

Responsibilities and Attributions of Researchers

(Excerpts from Resolution 466/2012 CNS/MS)

XI.1 – The researcher’s responsibility is non delegable and indeclinable and comprises legal and ethical aspects.

XI.2 – It is the researcher’s duty to:

1. register the research project on the Plataforma Brasil and wait for CEPSH approval before starting it;
2. develop the project as informed on registration;
3. prepare and present partial and final reports do CEPSH;
4. present data requested by CEPSH at any moment;
5. keep physical or digital records of the research data, under their care and responsibility, for 5 years after the end of the project;
6. submit the research results for publication, correctly crediting contributions form associate researchers and technical staff involved in the project; and
7. reasonably justify the interruption of the project or non publication of the results before CEPSH or CONEP.

Registration to Plataforma Brasil

Project submission to Plataforma Brasil

Report Itinerary

CONEP orientation on Thematic Areas

Models

Questions and assistance on projects

• Researcher’s Guide on Plataforma Brasil
• Frequent pendencies in Clinical Research Protocols