July 2018: Brazil Regulatory Updates

As per ResolutionNo466 and OSNo001/2013, Brazil has a centralized registration process for ethics committee (ECs) and requires institutional level EC approval for each trial site. The National Commission for Ethics in Research (Comissão Nacional de Ética em Pesquisa) (CONEP) serves as the central body that reports to the National Health Council (NHC) (Conselho Nacional de Saúde (CNS)), the advisory body for the Ministry of Health (MOH).

As indicated in ResolutionNo466 and OSNo001/2013, the EC system as a whole is known as the “CEP/CONEP System”. CONEP coordinates the network of institutional ECs, known as Committees of Ethics in Research (Comitês de Ética em Pesquisas) (CEPs). It is responsible for EC (CEP) accreditation and registration, and it prepares ethical guidelines and standards for the protection of human research participants. CONEP was originally established as a statutory body in 1996 under Resolution 196/96. This resolution was repealed in December 2012 and replaced by ResolutionNo466 in 2013. Each institution that conducts biomedical research is required to have an EC (CEP) that is responsible for reviewing clinical trial applications. In addition, applications with coordination or sponsorship originating outside of Brazil must also be approved by CONEP, unless the co-sponsor is the Brazilian Government. Please refer to Ethics Committee topic, Scope of Review and Authorizing Body subtopics for detailed information on CONEP responsibilities and other studies requiring CONEP approval.

OSNo001/2013 also indicates that the development and submission of research, as well as the implementation and disclosure of CEP and CONEP opinions, must occur through the Plataforma Brasil. According to Additional Resource (C), Plataforma Brasil was created to provide a national and unified registry for research involving human participants. The platform represents the review and approval processes of both the CEP and CONEP. Research applications can be tracked from submission to final approval by the CEP, and when necessary, by CONEP.

CONEP Composition

Please refer to Ethics Committee topic, Authorizing Body subtopic.

EC (CEP) Composition

As per the PANDRH-GCPs, an institutional EC (CEP) must have at least five (5) members who collectively encompass the qualifications and experience required to review and evaluate the scientific, medical, and ethical aspects of a proposed clinical trial. By comparison, the OSNo001/2013 and the OMREC require the EC (CEP) to be composed of a minimum of seven (7) members having proven expertise in research. The OSNo001/2013 also requires at least 50% of the members to have this research experience. The PANDRH-GCPs, the OSNo001/2013, and the OMREC also indicate that the EC (CEP) should be multidisciplinary, represent a balanced gender and age composition, and consist of members embodying community interests and concerns. The OSNo001/2013 and the OMREC also state that not more than half of its members should belong to the same professional category. In addition, as per the PANDRH-GCPs, in communities where minority ethnic populations predominantly reside, the EC (CEP) should include a member, alternate, or consultant from that group. The EC (CEP) may also designate alternate members whose functions are delineated in the EC’s (CEP’s) standard operating procedures (SOPs).

Additional criteria for EC (CEP) membership is available in Section 3.2 of the PANDRH-GCPs, Section 2.2 of the OSNo001/2013, and Section 2 of the OMREC.

Terms of Reference, Review Procedures, and Meeting Schedule

As set forth in the PANDRH-GCPs and the OMREC, each EC (CEP) must have written SOPs, including a process to be followed for conducting reviews. The SOPs should include information on EC (CEP) composition, meeting schedules, frequency of reviews, requirements for initial and ongoing evaluation of the research study, and requirements for notifying the investigator and the institution of results related to the study’s initial and ongoing evaluation.

Per the PANDRH-GCPs and the OMREC, the majority of committee members must be involved in the review and approval process, and the necessary quorum must be obtained to approve or deny permission to conduct a study as specified in each EC’s (CEP’s) SOPs. As per ResolutionNo370, the registration and appointment terms of EC (CEP) members are valid for three (3) years, and may be renewed at the end of that period.

The PANDRH-GCPs also state that the EC (CEP) must retain all relevant records (e.g., SOPs, member lists, member affiliations and occupations, documents presented, meeting minutes, and correspondence) for three (3) years after the study’s conclusion, and make them available to the regulatory authorities upon request.

For detailed EC (CEP) procedures and information on other administrative processes, see Sections 3.3 and 3.4 of the PANDRH-GCPs and the OMREC.

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