Plataforma Brasil (plataformabrasil.saude.gov.br) is Brazil’s single national portal for submitting research involving human participants to the country’s ethics-review system. Every researcher based at a Brazilian institution — and every foreign researcher collaborating on a study conducted in Brazil — registers the protocol here before enrolling a single participant. This guide explains what the portal actually requires: who has to use it, how the local committee (CEP) and the national commission (CONEP) divide the work, what a submission package contains, how to read the review statuses, how to clear a pendência, and how to file a substantive amendment (emenda) later. It also clears up the single most common confusion: Plataforma Brasil is an ethics-submission system, not a clinical trial registry.
What Plataforma Brasil is — and isn’t
Plataforma Brasil is run by Brazil’s Ministry of Health (Ministério da Saúde) on behalf of the National Health Council (Conselho Nacional de Saúde, CNS). It is the unified national database of record for research involving human subjects reviewed by the CEP/CONEP system: it tracks a protocol from initial submission through ethics approval, amendments, and closure.
It is not a clinical trial registry. Brazil’s WHO-recognised primary clinical trial registry is ReBEC (Registro Brasileiro de Ensaios Clínicos), a separate system maintained by Fiocruz for interventional trials. A trial sponsor in Brazil typically needs both: ethics clearance through the CEP/CONEP system in Plataforma Brasil, and, if the study is an interventional clinical trial, prospective registration in ReBEC (or another WHO primary registry) to satisfy the same trial-transparency norms covered in CASRAI’s guide to clinical trial registration and reporting compliance. If your study also requires drug or device regulatory clearance, that runs on a parallel, separate track through ANVISA — see CASRAI’s guide to ANVISA’s clinical trial approval pathway for how the ANVISA and CEP/CONEP tracks fit together.
Who has to use it
Any researcher aged 18 or older — Brazilian or foreign — who is conducting research involving human participants must register that research in Plataforma Brasil before it begins, regardless of discipline. This covers biomedical and clinical research under Resolution CNS 466/2012 as well as research in the social sciences and humanities under Resolution CNS 510/2016, which applies a distinct, lighter set of rules suited to non-biomedical methods (see below). Research using only public-domain data that doesn’t identify participants, or a pure literature review with no human participants, generally falls outside the CEP/CONEP system and doesn’t need a Plataforma Brasil submission — but that determination should be made deliberately, not assumed, since “involving human subjects” is interpreted broadly in the Brazilian system.
Plataforma Brasil vs. ReBEC: don’t confuse the two
Because both are national, government-run, Portuguese-language systems tied to human research, they’re frequently conflated. They do different jobs:
- Plataforma Brasil is where you get ethics approval for a study involving human participants. Every study in scope needs this, regardless of study design.
- ReBEC is where you register an interventional clinical trial for public transparency, matching the role that ClinicalTrials.gov or the ISRCTN registry play elsewhere. Only interventional trials need this, and it happens alongside, not instead of, ethics review.
Approval in Plataforma Brasil does not register your trial in ReBEC, and registering in ReBEC does not substitute for CEP/CONEP ethics approval. If your study is an interventional trial, budget time for both.
CEP vs. CONEP: who actually reviews your protocol
Brazil’s ethics-review system has two tiers, both operated inside Plataforma Brasil:
- CEP (Comitê de Ética em Pesquisa) — a local research ethics committee, based at a university, hospital, or research institution, and accredited by CONEP. A CEP is Brazil’s equivalent of an Institutional Review Board (IRB) in the US or a research ethics board elsewhere. Most protocols are reviewed and approved entirely at this level.
- CONEP (Comissão Nacional de Ética em Pesquisa) — the national commission, which accredits and oversees the CEP network and directly reviews protocols that fall into defined higher-oversight categories (below), rather than delegating them to a local committee.
You don’t choose which one reviews your study. When you register a protocol, Plataforma Brasil routes it to your institution’s linked CEP by default; the system (and the CEP itself, on initial review) determines whether the subject matter requires it to be forwarded to CONEP instead.
When a protocol escalates to CONEP
Under Resolutions CNS 466/2012 and 510/2016, CONEP itself — rather than a local CEP — directly reviews protocols in a defined set of “special thematic areas.” Based on CONEP’s own published guidance, these areas include (among others) research involving:
- Human genetics and reproduction;
- New equipment or devices for health, and new procedures not yet established in clinical practice;
- Indigenous populations;
- Projects linked to biosafety.
Separately, Resolution CNS 580/2018 sets out an expedited review track for research designated as strategic to Brazil’s public health system (SUS). If your protocol touches any of these areas, expect it to be routed to CONEP rather than closed out at the local CEP, and expect the review to take longer than a standard local-CEP review. Confirm the current thematic-area list directly with your CEP or CONEP before submitting, since these categories are set by council resolution and can be revised.
Registration and the researcher profile
Before you can submit anything, you need a personal Plataforma Brasil account (a cadastro de pesquisador). Registration asks for your identifying documents, contact details, and institutional affiliation, and links your account to a Currículo Lattes — the CV embedded in Brazil’s national researcher-CV platform. If you haven’t used Lattes before, see CASRAI’s guide to the Lattes Platform for how that registration works, since Plataforma Brasil expects it as a prerequisite rather than an optional add-on.
Once your personal profile is active, you register the study itself as a new project, select the institution proposing the research (instituição proponente), and select the CEP that institution is linked to. Foreign researchers without a Brazilian institutional affiliation generally need a Brazilian co-investigator or partner institution to act as the proposing institution, since Plataforma Brasil is built around an institutionally anchored submission model.
What a submission requires
A complete initial submission in Plataforma Brasil typically includes:
- Folha de rosto (cover sheet) — a form the platform generates from your project data, identifying the project, the responsible researcher, and the proposing institution. It carries the legal signatures committing the researcher and institution to the applicable norms, and is uploaded back into the system as a signed document.
- TCLE (Termo de Consentimento Livre e Esclarecido) — the informed consent form, required under Resolution CNS 466/2012 unless a specific, justified waiver applies. This plays the same role as an Informed Consent Form (ICF) in other national systems.
- Detailed project file (projeto detalhado / protocolo de pesquisa) — the full research protocol.
- Supporting documents such as the researcher’s identification and Lattes CV, and, depending on the study, additional institution-specific authorizations.
Submission through Plataforma Brasil itself is free of charge; there is no government filing fee to submit a protocol.
The review workflow and what the statuses mean
Once submitted, a protocol moves through a small set of status labels inside Plataforma Brasil. The exact wording can vary slightly by CEP, but researchers most commonly see:
- Em Análise — under review by the CEP (or CONEP).
- Pendência — the committee has returned the project with specific items that need correcting or clarifying before it can be approved. This is not a rejection.
- Aprovado — approved. The committee issues a CAAE-linked approval document (Parecer Consubstanciado do CEP) that the researcher can download from the platform.
- Não Aprovado — not approved.
Every project registered in Plataforma Brasil is assigned a CAAE (Certificado de Apresentação de Apreciação Ética) number the moment it’s submitted. Keep this number on hand — it’s the reference used in all further correspondence, amendments, and the eventual approval certificate.
Responding to a pendência
A pendência is the CEP’s (or CONEP’s) list of specific, itemized issues with your submission — missing information, a clause the TCLE needs to add, a methodological point that needs clarifying. It is normal: a large share of first submissions come back with at least one pendência, and it does not restart your project as new.
To respond, you edit the flagged sections of the existing project inside Plataforma Brasil (you don’t create a new submission) and typically attach a short response letter (carta resposta) that addresses each point the committee raised, one by one, so the reviewer can see exactly what changed and why. Resubmitting moves the project back into the CEP’s review queue; because most Brazilian CEPs review submissions on a scheduled meeting cadence rather than continuously, turnaround after a resubmission depends on that committee’s own meeting schedule rather than a fixed national deadline.
Making a substantive change: the emenda process
Once a protocol is approved, any material change — to the methodology, the consent form, the research team, the timeline, or the participating sites — has to go through Plataforma Brasil as a formal amendment (emenda), not as an informal note to the committee. An emenda is filed against the existing, already-approved project (using its CAAE number) rather than as a new submission, and is routed to whichever body approved the original protocol — the local CEP, or CONEP if CONEP reviewed the original study. This is the same underlying discipline covered generally in CASRAI’s explainer on the difference between a protocol amendment and a minor administrative change, and in the comparison of what does and doesn’t need full ethics review: not every change to a study needs a formal emenda, but anything that affects risk to participants, the consent process, or the study’s scientific design does.
The ethical framework behind the system: Resolutions 466/2012 and 510/2016
Two CNS resolutions set the substantive rules Plataforma Brasil enforces procedurally:
- Resolution CNS 466/2012 is Brazil’s core ethical framework for research involving human subjects in health and biomedical fields — it sets out informed consent requirements, risk-benefit assessment, and the CEP/CONEP oversight structure itself.
- Resolution CNS 510/2016 applies specifically to research in the humanities and social sciences. It was created because 466/2012’s biomedical framework didn’t fit methods like ethnography, oral history, or documentary research well, and it sets out different rules — including narrower exemptions for certain low-risk social-science designs — more suited to those methods. A social-science researcher submitting through Plataforma Brasil should confirm their CEP is applying 510/2016 rather than the biomedical 466/2012 framework by default.
If your research also involves questions of personal data handling separate from informed consent — secondary use of records, anonymization, data retention — see CASRAI’s guide to Brazil’s LGPD and research data, which covers the academic-purpose and anonymized-data exemptions relevant to Brazilian data protection law separately from CEP/CONEP ethics review.
Frequently asked questions
Is Plataforma Brasil a clinical trial registry?
No. It’s the national ethics-submission and review system. Brazil’s clinical trial registry is ReBEC, a separate platform. An interventional trial normally needs both.
Do I need to submit to CONEP, or just my local CEP?
By default your protocol goes to your institution’s linked CEP. It’s escalated to CONEP only if it falls into one of the special thematic areas set out in Resolutions 466/2012 and 510/2016 (for example, human genetics, new health devices or procedures, indigenous populations, or biosafety-linked research) or is designated strategic for the public health system under Resolution 580/2018.
What does a pendência mean, and is it a rejection?
It means the committee needs specific corrections or clarifications before it can approve the study. It is not a rejection — you edit the flagged parts of your existing submission and respond directly to each point raised.
Is there a fee to submit through Plataforma Brasil?
No. Submission through the platform is free of charge.
Does social-science research follow the same rules as clinical research?
No. Social sciences and humanities research is governed by Resolution CNS 510/2016, a separate, more discipline-appropriate framework from the biomedical Resolution CNS 466/2012 — confirm your CEP is applying the correct one to your study.
What do I need before I can register a project?
A personal researcher account in Plataforma Brasil linked to a Lattes CV, and a Brazilian proposing institution with a linked CEP. Foreign researchers without a Brazilian affiliation typically need a Brazilian institutional partner to submit through.
