Centralized vs decentralized ethics review across Latin American clinical trials

Not every Latin American country runs clinical-trial ethics the same way. Some markets clear institutional research ethics committees (RECs) in weeks. Others stack a national health-authority desk on top of — or instead of — the hospital committee. Treating “LATAM ethics” as one bottleneck is how a US MedTech startup mis-prices a first-in-human calendar by 60–90 days.

I am Julio Martinez-Clark, CEO of bioaccess®. This page is the ethics-architecture cut: institutional versus centralized review, where parallel submission is real, and how that should change country pick for FIH versus feasibility versus pivotal work. Clocks below are already published on country hubs and FIH guides — not new invented medians.

Two architectures, not one “LATAM IRB”

Institutional / Type II committee first. A CNBI-registered or nationally accredited hospital or network committee reviews the protocol, consent, and investigator packet. The national authority may run in parallel or after, depending on the statute.

Centralized / multi-tier. A national ethics or health-research desk is on the critical path before first patient — sometimes after local review, sometimes as the primary gate. Startup time stretches when you serialize desks that the statute allows to run together.

The myth to retire: every LATAM country waits on the same centralized government bottleneck. The operator question is which desks are parallel and which are serial.

Country snapshots sponsors actually use

Panama — parallel MINSA + Type II ethics

Ley 84 of 14 May 2019 and Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C) put clinical trials on Type II-accredited committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Ordinary ethics review is capped at 20 business days. High-risk protocols — Class III implants and novel biomaterials — get parallel MINSA + ethics, not a forced serial queue. RESEGIS registration before start; standard projects get a registration receipt in three business days. Practitioner ethics band already on the hub: 3–5 weeks, with MINSA clearance available concurrently on the high-risk track. See Panama Class III FIH and the Decreto 21 explainer.

Dominican Republic — institutional REC speed on a DIGEMAPS file

The Dominican Republic is a lead first-in-human jurisdiction for bioaccess®. Local research ethics committee review sits with the site; the national health-authority file (DIGEMAPS / CONABIOS path as published on the CRO in Dominican Republic page) is a separate operating problem. Do not confuse a fast institutional REC letter with a complete national authorization package — and do not invent a CONABIOS median that is not on the live page.

El Salvador — DNM/SRS as the trial desk

El Salvador is a published lead FIH geography under DNM/SRS. Trial authorization and ethics sit on that country’s rulebook (Acuerdo 838 BIS and related instruments already cited in our regulatory notes). Use the published 30–60 day trial-authorization band from the FIH cost page — not a new clock here. See Panama / El Salvador FIH cost vs US.

Colombia — ethics plus INVIMA CTA (new FIH not recommended)

Colombia still has institutional CEI/IRB review and an INVIMA clinical-trial authorization track under the published decree/resolution stack (Decreto 4725/2005; Res. 2378/2008 and related). Commercial INVIMA registro remains a core bioaccess® market-access service. Because INVIMA clinical-trial approval timelines have become unpredictable, bioaccess® does not currently recommend Colombia for new first-in-human trial execution. Keep ethics speed and INVIMA CTA risk on separate lines in the budget.

Brazil — CEP then CONEP / ANVISA for many device paths

Brazil’s ethics architecture is multi-tier for a large share of interventional research: local CEP review, with CONEP involvement when the study type requires it, plus ANVISA on the regulatory side. That is a serialized or partially overlapping national stack — plan months, not the Panama 3–5 week ethics band. Use ANVISA/CEP guidance already on Brazilian market-access and trial pages; do not paste a Panama clock onto a Brazilian FIH.

Mexico — COFEPRIS and institutional review

Mexico pairs institutional ethics with COFEPRIS authorization for many investigational and commercial paths. COFEPRIS vía abreviada and holder/IOR rules are commercial-registration facts (see the Mexico COFEPRIS holder page). For trials, treat COFEPRIS as a national desk on the critical path — not an institutional REC-only country.

Chile — ISP and institutional ethics

Chile runs institutional ethics with ISP (Instituto de Salud Pública) on the sanitary/clinical side under the published Código Sanitario / ISP resolution stack. Recent registration waves (including Decreto Exento N° 25 of 2026 on the commercial side) do not erase the trial/ethics split. Use Chile country pages for study-specific clocks; do not invent a national ethics median here.

Parallel submission: where 60–90 days come from

The savings appear when you stop serializing desks the statute allows to run together:

• Panama high-risk: open MINSA and Type II ethics in parallel; register in RESEGIS before start.
• Import file: start insurance, Spanish IB, and import permit drafting while ethics is open — not after the stamp.
• Site contracts: do not wait for the national letter to begin CTA negotiation when the site will accept a parallel pack.

Serialize only when the law requires it (many Brazilian and some Mexican paths). Forcing serial review in a parallel country is a self-inflicted quarter.

Match architecture to clinical phase

• FIH / early feasibility (small n). Prefer markets with institutional or parallel Type II review and published short ethics bands — Panama and El Salvador as lead examples on our hubs. Design the file for 21 CFR 812.28 inspectability from day one.
• Feasibility / expansion cohorts. Add a second country only when enrollment or indication density requires it — keep ethics architectures compatible so monitoring and AE dictionaries stay one system.
• Pivotal / multi-country. Budget for centralized desks (Brazil, parts of Mexico) and do not price the whole program on a Panama ethics band.

One-page gate before you pick the country

1. Which desks are on the critical path? Institutional only, parallel national + ethics, or serialized national.
2. Is parallel submission written into the statute or decree? Panama Decreto 21 high-risk is yes. Do not assume the same elsewhere.
3. Spanish packet ready? Protocol, IB, consent, insurance — foreign-language drafts do not substitute.
4. US filing intended? If yes, ethics speed without 812.28 documentation is a false economy.
5. Colombia new FIH? Default no for new first-in-human execution; yes for commercial registro conversations.

If you are choosing between Panama, El Salvador, the Dominican Republic, Chile, or a multi-country plan, send bioaccess® the protocol stage, device risk class, intended US filing, and target first-patient month. We will map the ethics desks — not a brochure “LATAM IRB” average.

Related: clinical trials, market access, and Australia vs Latin America for FIH.