Clinical research is any scientific research that involves human beings aiming to investigate the effects of a drug or active (such as a medication, supplement or cosmetic), of an equipment (such as lasers and others), or of techniques and procedures for medical or cosmetic purposes. The terms “clinical trial” and “clinical study” are synonyms.
All clinical trials must be performed according to a clinical protocol previously approved by an Institutional Review Board (IRB) or an Independent Ethics Committee (IEC).
In Brazil, the clinical research is regulated by the resolutions of the National Health Council (CNS) and the Brazilian Health Regulatory Agency (ANVISA). Besides, any research on human beings in Brazil must follow the guidelines of Good Clinical Practices.
1988: Publication of Resolution 1/88. First resolution created to regulate health research.
1996: Publication of ICH/GCP (Good Clinical Practice of International Conference on Harmonization), a document that establishes guidelines for the quality of clinical trial procedures to guarantee the safety, the rights and the well-being of trial participants. It was established by the European Community, USA and Japan and served as a basis for Resolution 196/96 of the National Health Council.
1996: Publication of Resolution 196/96 by National Health Council, which created the National Research Council (CONEP). It determines the guidelines to conduct clinical researches in Brazil.
1999: Creation of the Brazilian Health Regulatory Agency (ANVISA).
2005: Creation of the GCP for the Latin American Countries, also known as Document of the Americas. This document, likewise the ICH/GCP, establishes ethical and scientific quality standards to plan, conduct, record and report clinical trials.
2012: Publication of Resolution CNS 466, which provides the new national guidelines for conduct of clinical research in Brazil.
It is the document that states the scientific basis and that defines the methodology of the research to be performed.
The research objectives and duration, evaluations and treatments, and the number of trial participants required for the study must be described in this document.
It also describes the criteria for the subjects’ participation in the study. Those who meet all criteria and are willing to perform the study procedures can be enrolled in the study.
We emphasize that participation in clinical trials is voluntary and it is free (participants cannot be charged for any research procedure). In Brazil, participants cannot be paid for enrolling a study, except for some cases of safety trials.
It is the document that registers the consent of the subject or of his legal guardian to enroll in a study. In this document, all information about the trial is presented in a clear, objective and easy-to-understand language.
Important: clarify any doubts before consenting to participate in a trial!
Institutional Review Board (IRB)/Independent Ethics Committee (IEC): responsible for approving the clinical study protocols and monitoring the clinical trials.
National Research Council (CONEP): responsible for the ethical analyzes based on the rules and guidelines of research with human beings.
Brazilian Health Regulatory Agency (ANVISA): responsible for sanitary control of products and services, and it regulates the entry of drugs not yet registered in the country.