One study, two ethics reviews. How the Brazilian one works.

Your IRB’s approval doesn’t cover the Brazilian side

Brazil reviews research with people on its own terms. Law No. 14,874 of May 28, 2024, puts research with human beings through an ethics review before it starts (art. 6), in all fields of knowledge, the human and social sciences included (art. 63). The review is done by a CEP, a Comitê de Ética em Pesquisa, attached to a research institution (art. 2, X).

Approval abroad doesn’t replace it. The Brazilian review reads the study from the participants’ side: how they’re invited, what the consent form tells them in Portuguese, what they’re reimbursed, and where their recordings go.

The 2024 law is still being put into practice

Before the law, research ethics in Brazil ran on resolutions of the National Health Council (CNS), applied by the CEPs and, for some studies, by CONEP, the Comissão Nacional de Ética em Pesquisa. The law created a national body for oversight, and Decree No. 12,651 of October 7, 2025, regulated the law and organized that body, the Instância Nacional de Ética em Pesquisa (Inaep), whose members began work in February 2026. CONEP kept only the appeals until they took office (decree, art. 40).

Inaep hasn’t yet published rules to replace the CNS resolutions. Until it does, those resolutions apply wherever they don’t contradict the law or the decree (art. 39): Resolution 466 of 2012 for research in general, and Resolution 510 of 2016 for the human and social sciences. Protocols still go in through Plataforma Brasil, the national online system, while the Ministry of Health builds a new platform (art. 8).

More is on the way. A draft rule on risk classification is open for public comment until December 26, 2026, and the decree has Inaep write a separate rule for the human and social sciences (art. 35). Before you submit, ask your Brazilian partner’s CEP which procedures it is applying that month.

A Brazilian researcher and institution answer for the study

Resolution 466 asks that research conducted abroad, or with foreign cooperation, name a researcher and an institution in Brazil as responsible for it there (item III.2.p). For an interview study, that usually means a co-investigator at a Brazilian university or research institute, whose institution is the proposing institution in Plataforma Brasil. The protocol goes to the CEP linked to that institution.

The same item asks the protocol to show the study’s commitments and benefits for the participants and for Brazil, and asks studies sponsored from abroad to pass knowledge and technology on to the Brazilian team where that applies.

Studies led from abroad currently go to an accredited committee

The law sorts CEPs into two kinds: credentialed ones review research of low or moderate risk, and accredited ones review high-risk research as well, which only they may do (art. 9, §1).

Inaep hasn’t yet set the criteria for high risk. Meanwhile, the Ministry of Health treats as high risk the special areas of Resolution 466, the ones CONEP used to review (Technical Note No. 43/2025). One of them is research coordinated or sponsored from outside Brazil, unless the Brazilian government co-sponsors it (item IX.4, area 8). A study led from abroad is therefore reviewed by an accredited CEP.

If your partner’s CEP is credentialed but not accredited, it checks the area and forwards the protocol through Plataforma Brasil to Inaep, which assigns it to an accredited CEP. The forwarding opinion reads Aprovado, but only to move the file: it isn’t an ethical approval and doesn’t let the study start (Technical Note No. 1/2026).

This may change. The draft rule under public comment proposes that an international design should not, by itself, decide a study’s risk category, except where a rule says so (Inaep, Vote No. 29/2026).

The law counts the committee’s time in working days

Once the protocol is submitted, the CEP has 10 working days to accept the documents as complete or turn them down, and then 30 working days to issue its opinion (art. 14). If the committee asks for more information or changes, the count stops for up to 20 working days. The researcher has 10 working days to answer, which can be extended once by the same period with a reason, and a late answer can end the review (§§ 1 and 2).

Added up, a review with one round of questions can take 60 working days, about 12 weeks, before any forwarding to an accredited CEP. An opinion can be appealed within 30 working days, first to the same CEP and then to the national body, and each appeal is decided within 30 working days (§§ 5 and 6). A study with several centers in Brazil gets a single review, preferably by the CEP of the coordinating center (§ 7).

The consent form is written for the participant, in Portuguese

The form is the TCLE, the Termo de Consentimento Livre e Esclarecido. The law asks for plain language and a form dated and signed by the researcher responsible and by the participant, or by an impartial witness when the participant can’t read (art. 18). Resolution 466 asks that forms in studies conceived abroad be adapted to Brazilian ethics rules and to local culture, and that they be made in two copies, initialed on each page and signed on the same sheet (item IV.5).

A form translated line by line from a template used abroad can leave out what a CEP looks for. Resolution 510 lists the contents for the human and social sciences (art. 17), and the law adds to them. Among them:

• a sentence on what a CEP is, with the address, email, and phone number of the CEP and of the researchers (Resolution 510, art. 17, VIII and IX);
• the right to be reimbursed for expenses and how they’re covered (art. 17, VII), with the amounts and how often they’re paid (the law, art. 12, VII);
• the right to assistance, and to seek compensation, for harm from taking part, whether the form foresaw it or not (Resolution 510, art. 19, §2);
• access to the results (art. 17, VI), and to the consent record whenever the participant asks for it (art. 17, X).

Nothing in the form, or said aloud, may suggest that the participant gives up rights, or that the researcher, the institution, or the sponsor is exempt from responsibility for harm (the law, art. 18, §3).

Resolution 510 lets studies in the human and social sciences record consent in other forms, such as audio or video, when the researcher justifies the choice (arts. 15 and 16), and CONEP issued guidance in 2022 for electronic consent, with the signed copy sent to the participant and a link to withdraw (Circular Letter No. 23/2022). The law’s general rule, though, is a signed and dated form, and Inaep has yet to write the rule for the human and social sciences, which is to provide for consent in formats adapted to the social and cultural context (decree, art. 35). Until it does, ask your partner’s CEP which consent records it accepts before you plan the fieldwork around one.

We translate consent forms and participant information sheets from English into Brazilian Portuguese for the CEP. If the committee has its own template, send it with them.

Participants are reimbursed, never paid

The law prohibits paying participants or giving them any kind of advantage for taking part (art. 20). What it allows is reimbursement: transport and food, material support given in advance, and other costs the project makes necessary (§1). The only exception is for healthy volunteers in phase I clinical trials and bioequivalence studies (§2).

So the gift card or cash incentive common in interview studies elsewhere isn’t allowed in a Brazilian protocol. Budget for reimbursement, such as the bus fare to the interview or a meal during a long focus group, and write the amounts into the consent form, since the CEP has to check that they’re there (art. 12, VII).

Recordings and transcripts belong in the protocol

The law has the institution running the research keep its data for five years after the study ends, under the researcher’s responsibility, unless the CEP approves another period (art. 51 and §3). The institution shares only anonymous or coded data, and the key to the codes stays with whoever manages the data (§1). If the data are stored outside Brazil, the institution running the research answers for that (§2).

When consent is taken online, CONEP’s 2022 guidance makes the researcher responsible for storing what is collected and keeping it confidential, and asks the protocol to state the risks of the virtual environment and the measures taken. The protocol should also say who transcribes the recordings and who translates them, where the files go, and when they are deleted.

We answer those questions in writing before any audio reaches us. The data handling page shows the whole path.

Six things to have ready before you submit

1. A partner in Brazil, and their CEP. Ask early whether that committee is accredited. If it isn’t, a study led from abroad is forwarded to one that is, which adds a step.
2. Your home approval. The Brazilian rules on studies with foreign participation list the approval of an ethics committee in the country of origin among the protocol’s documents, or a reason when the study won’t run there (Resolution 292/1999, items VII.1 and VII.2).
3. The consent form in Portuguese, with the Brazilian items, on the CEP’s template if it has one, and the interview guide.
4. A reimbursement budget instead of incentives, with amounts the consent form can state.
5. The path of the recordings. Who transcribes them, who translates, where the files are kept, and for how long.
6. Time. On paper, about 12 weeks from submission with one round of questions, and longer if the protocol is forwarded.

This page follows the official texts

Read against these texts in October 2026, all of them in Portuguese. Where a text and this page differ, the text and your CEP prevail.

• Law No. 14,874 of May 28, 2024, research with human beings and the national system of research ethics
• Decree No. 12,651 of October 7, 2025, regulates the law and sets up Inaep
• CNS Resolution No. 466 of December 12, 2012, research with human beings in general
• CNS Resolution No. 510 of April 7, 2016, the human and social sciences
• CNS Resolution No. 292 of July 8, 1999, research with foreign participation
• Ministry of Health, Technical Note No. 43/2025, risk classification and routing during the transition
• Ministry of Health, Technical Note No. 1/2026, forwarding high-risk protocols to accredited CEPs
• CONEP Circular Letter No. 23/2022 of October 17, 2022, electronic consent
• Inaep, public consultation on risk classification, open October 28 to December 26, 2026, with Vote No. 29/2026