Figure 1
Brazilian Clinical Research Timeline. In Brazil, Clinical Research is an area in constant evolution, regulated by ethical and regulatory instances. The national ethics system, composed by the National Commission for Ethics in Research (CONEP) and the Research Ethics Committees (RECs), was introduced in 1996 through Resolution No. 196, subsequently revoked by Resolution No. 466/2012, and it is based on the main international documents which issued declarations and guidelines about research involving human beings: Nuremberg Code (1947), Helsinki Declaration (1964 and its later versions of 1975, 1983, 1989, 1996, 2000, 2008, and 2013), the International Covenant on Civil and Political Rights (ONU, 1966), and the Universal Declaration on Bioethics and Human Rights, in 2004. Since its creation, dozens of resolutions, operational standards, and circular letters were published, focusing on the operationalization of the system and guarantee of rights, well-being, and protection of research participants, such as the Resolution No. 370/2007, which deals with registration, accreditation, and renewal of RECs, the Operational Standard No. 001, about the organizations and operation of REC/CONEP system and the procedures for submission, evaluation, and monitoring of research involving human beings, the Resolution No. 510/2016, which brings specific regulations for research in Social and Human Sciences and Resolution No. 563/2017, which deals with the post-study access right of participants with ultra-rare diseases. A bill No. 200/2015 (current No. 7.082/2017) has been in progress since 2015, bringing changes to several aspects of the national ethics system in research projects, including the establishment of a new body to review and authorize protocols. From the regulatory point of view, long before the establishment of the largest regulatory agency in the country – Brazilian Health Surveillance Agency (ANVISA) –, the regulation of products for human use, such as drugs and pharmaceuticals supplies, for example, was already a concern in Law No. 6.360 of 1976. More than 10 years have passed until the publication of Resolution No. 1/88, the first one to standardize health research. In 1999, the same year in which the Brazilian Society of Professionals in Clinical Research (SBPPC) was founded, ANVISA was created, aiming at the protection and promotion of health for Brazilian citizens through the regulation of health products and services. Since 2013, ANVISA has been working on the regulation for clinical trials with drugs, devices, and advanced cell therapies. In March 2015, ANVISA published two resolutions, changing the submission process in Brazil. Resolutions RDC No. 09/2015 (for clinical trials with drugs) and RDC 10/2015 (for clinical trials with devices) started a process similar to the Investigational New Drug (IND) process of the U.S. Food and Drug Administration (FDA). In 2016, ANVISA was accepted as a new member of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical Products for Human Use (ICH). Revoking N.I. No. 4/2009, the normative instructions No. 20 and 21 were published in 2017, regulating procedures of inspection in Good Clinical Practices for clinical trials with drugs and medical devices, respectively. In 2018, RDC No. 260 was published, determining rules for clinical trials with advanced therapy products and establishing a regulatory mark about the topic. In the same year, reflecting concerns about transparency in handling and storage of personal data comes Law No. 13.709, also known as Brazilian General Data Protection Law, applied to both individuals and legal entities, aiming at guaranteeing privacy and data protection to users of several services, including the research participant.
EBSERH: Brazilian Company of Hospital Services; GCP: good clinical practices; M.H.: Ministry of Health; NCH: National Council of Health; N.I.: normative instruction; RDC: resolution of the collegiate board; Res.: resolution; SBPPC: Brazilian Society of Professionals in Clinical Research.