By Julio G. Martinez-Clark
CEO, bioaccess®
General information, not legal or regulatory advice. Requirements are cited to the regulation, the committee’s own manual or the regulator’s page. Each ethics committee can ask for more than the national minimum, so confirm the list with the committee before you file.
In this guide: The short answer · Clocks at a glance · The core packet · Country table · How many committees · Drugs vs devices · Checklist · What gets missed · Glossary · FAQ · Sources
The short answer
Every country in this guide requires ethics committee approval before an interventional clinical trial can enroll. The typical packet is industry standard: protocol, investigator’s brochure, informed consent form, recruitment materials and investigator CVs, plus good clinical practice (GCP) certificates and proof of insurance, which most Latin American countries require. The ethics principles are the same for drug and device trials; device trials add device-specific technical documents.
What changes by country is the detail, and the detail is what causes questions and delays:
- Who reviews. A committee at each institution (Mexico, Colombia, Peru), a single committee for a multicenter study (Brazil), an institutional committee plus a national body (Uruguay, the Dominican Republic, Costa Rica), or one national committee (El Salvador).
- Language. Spanish (or Portuguese in Brazil) for the protocol, consent and participant materials. Ecuador asks for an official translation of documents in other languages.
- Country documents. Examples: an insurance policy that applies in El Salvador, an insurer registered in Ecuador, apostilled foreign documents in El Salvador, a consent form stamped on every page in Guatemala, and the study budget in Colombia.
- Fees. Mexico’s committees do not charge sponsors, and Brazil’s transitional CEP/CONEP rules do not allow committees to charge for review. Panama allows fees. Peru’s committees each set their own. El Salvador’s committee publishes a fee schedule.
- Clocks. From 10 to 20 business days in Panama to 60 business days in Ecuador. Brazil’s committees have 10 business days to check completeness and 30 business days to give an opinion.
Ethics approval is one step in site activation. For the regulator’s review clock, see our regulator approval times guide; for the full path to first patient, see our site activation timeline guide.
Committee clocks at a glance
Only some countries publish an ethics committee clock. Most clocks start when the file is complete, and the time you spend answering questions is usually not counted.
The core packet every committee expects
These documents follow the international good clinical practice standard (ICH E6) for drugs and ISO 14155 for devices. They appear in most countries’ lists in some form; each committee can set its own list, so treat this as a preparation checklist:
| Document | What the committee checks | Device trials |
|---|---|---|
| Protocol, with version and date | Design, risks and benefits, vulnerable populations, statistics | Same |
| Investigator’s brochure | Safety, preclinical and prior clinical data | Device investigator’s brochure or equivalent, with risk analysis and instructions for use |
| Informed consent form, local language | Clear language, voluntariness, injury coverage, confidentiality, right to withdraw | Same; explains the procedure and device |
| Recruitment ads and participant materials | Accuracy, no undue influence | Same |
| Investigator CVs and GCP certificates | Qualified team at the site | Same, plus device training where relevant |
| Insurance policy or certificate (required in most Latin American countries) | Coverage for participants in that country | Same |
| Site or institution authorization | The institution agrees to host the study | Same |
| Contract and budget (some countries) | Payments to participants and sites, no cost to participants | Same |
Ethics committee requirements by country
| Country | Who reviews | Country-specific documents and format | Fees | Committee clock | Official source |
|---|---|---|---|---|---|
| Argentina | An accredited research ethics committee in the jurisdiction of each site. | After ANMAT authorizes the study, each site is authorized by, or notified to, ANMAT with its accredited committee’s approval. Committee accreditation is handled by each jurisdiction; confirm the local document list. | Confirm with the committee. | Set by the committee and jurisdiction. | ANMAT Disposition 7516/2025 |
| Brazil | Research ethics committee (CEP). For a multicenter study, a single CEP, preferably the coordinating center’s, reviews and notifies the other sites’ CEPs (Law 14,874, Art. 14). Under the transitional CEP/CONEP rules, the national commission (CONEP) also reviews special areas such as human genetics, reproduction and indigenous populations. Brazil is moving to a new national system; its national authority (INAEP) was appointed in July 2026. | Consent and participant materials in Portuguese. Drug trials need both ethics and ANVISA approval to start. A decree allows an integrated ethics and ANVISA review. | Committees may not charge sponsors for review under the transitional CEP/CONEP rules. | Completeness check within 10 business days; opinion within 30 business days of accepting the documents. Questions suspend the clock for up to 20 business days; the researcher has 10 business days (extendable by 10) to answer. | Law 14,874/2024; ClinRegs Brazil |
| Chile | An accredited scientific ethics committee (CEC). In multicenter studies, one committee reviews and each site carries out a local evaluation. | For drug trials, the ISP file includes the protocol and investigator’s brochure in English and Spanish, the consent approved by the committee, the committee’s favorable report and an insurance policy. | Confirm with the committee. | 45 days for the committee’s report, extendable once by 20 days (Supreme Decree 114, Art. 18). | Supreme Decree 114/2010; InvestChile |
| Colombia | The research ethics committee (CEI) of the site. For drug trials, the institution needs a current good clinical practice certificate from INVIMA. | For studies with medicines, INVIMA’s 2025 committee guide lists the investigator’s brochure; CVs (the principal investigator needs the specialty, 3 years’ experience and a GCP certificate no older than 3 years); protocol; consent form under Resolution 8430 of 1993; recruitment materials; the study budget; and the contract. Device studies go to an INVIMA-approved committee too; see our Colombia device walkthrough. | Confirm with the committee. | Set by the committee’s meeting calendar. | INVIMA guide ASS-RSA-GU040; Resolution 8430/1993 |
| Costa Rica | An ethics committee (CEC) accredited by the national council, CONIS. The CEC then files the approved protocol with CONIS. | CONIS publishes the registration requirements the CEC files. At social security (CCSS) hospitals, research can start 8 days after the investigator is notified of the CONIS registration and receives the ethics approval documents (CCSS instruction). | Confirm with the committee. | Committee: confirm with the CEC. Next step, CONIS: acknowledgment within 5 business days; technical report within 10 business days of assignment. | CONIS registration requirements |
| Dominican Republic | The ethics committee of the site (or a recognized independent committee), then the national bioethics council (CONABIOS). | Filed in person: the protocol in its original language with a faithful Spanish translation, a bound original and a digital version. The CONABIOS file includes the site committee’s approval, a letter from the site director, a no-objection letter from the national health service (SNS) for public sites, CVs with current GCP certificates, the insurance policy and the detailed budget. Submit at least 60 days before the planned start (Provision 004-A-2004). | Confirm with CONABIOS. | CONABIOS: final result within 45 business days; 21 calendar days for urgent protocols. | CONABIOS manual; submission requirements |
| Ecuador | A research ethics committee (CEISH) approved by the Ministry of Public Health. | The list includes the protocol in its original language and in Spanish; consent in Spanish or the participants’ ancestral language; an insurance policy from an insurer registered in Ecuador; the principal investigator’s registration with the national science agency (SENESCYT); for multicenter trials, the ethics approval from the sponsor’s home country; and the sponsor–investigator contract. All documents in Spanish, with an official translation where needed. | Confirm with the committee. | Opinion within 60 business days for clinical trials, counted as a legal término; 45 for studies on expedited review; up to 30 more days when clarifications are requested. | Ministerial Agreement 00005-2022 |
| El Salvador | The national ethics committee (CNEIS), through a platform shared with the regulator, SRS. The SRS route lists CNEIS approval before the regulator’s authorization. | Ethics step: submission letter, application form, proof of fee payment, investigators’ medical licenses, the institution’s operating license (private sites), delegation letter and conflict-of-interest declaration. Shared step: investigator’s brochure, consent with version and date, an insurance policy that applies in El Salvador, the site’s authorization letter, CVs and GCP certificates for all staff, the protocol and the sponsor–investigator contract. Foreign legal documents must be apostilled or legalized. | CNEIS publishes review fees by applicant type; confirm the current amount. | 20 business days for CNEIS approval (SRS route). | SRS–CNEIS platform instructions; CNEIS |
| Guatemala | An ethics committee authorized and listed on the national registry of the regulator, DRCPFA. | The consent form must be foliated and stamped, signed and dated on every page by the committee president, coordinator or a member the committee designates. The DRCPFA file includes the committee’s favorable report and a copy of the insurance policy. | Confirm with the committee. | Committee: confirm with the committee. Next step, DRCPFA: 30 business days after a complete file. | Ministerial Agreement 206-2021 |
| Mexico | The institution’s ethics and research committee (CEI), plus the biosafety committee where applicable. The committee approves before COFEPRIS reviews. | All documents in Spanish. Since May 2026, the COFEPRIS application carries the committee’s approval and its registration, replacing the 2025 single committee form. | Ethics committees do not charge sponsors; the institution funds them. | The national committee guide recommends a decision within 5 working days of the meeting, and no more than 30 calendar days from the request. | ClinRegs Mexico; DOF, 28 April 2025; DOF, 4 May 2026 |
| Panama | A research ethics committee accredited by the national bioethics committee (CNBI). The CNBI reviews new high-risk technologies and hears appeals. | Submissions are electronic; the printed consent and participant materials follow approval. Documents in Spanish. The study is registered in the national research registry, RESEGIS. | Committees may charge fees. | Up to 20 business days (10 expedited). If the study returns to the full committee after the first review, the total is 30. Time spent answering is not counted. Appeals to the CNBI are decided within 20 business days. | Executive Decree 21/2026 |
| Peru | An institutional research ethics committee (CIEI) registered with, and for drug trials accredited by, the national institute of health (INS). | The committee approves the protocol and consent form before the INS application; the INS receives the committee-approved versions. Protocol and investigator’s brochure in Spanish, with the original. | Each committee sets its own fees. | Each committee sets its own timeline. | ClinRegs Peru (Supreme Decree 021-2017-SA) |
| Uruguay | The institutional ethics committee, plus the national commission (CNEI) for multicenter single-opinion studies, vulnerable populations, biosafety, and trials of new drugs, indications, vaccines, diagnostics, devices or invasive procedures. | Documents in Spanish, with the originals. The insurance must be identified. | Confirm with the committee. | 60 days for the institutional committee; 60 days, extendable, for the CNEI. Investigators have 60 days to answer questions. | Decree 158/019 |
| United States | An institutional review board (IRB). | The IRB reviews the protocol, consent, recruitment materials and investigator information under FDA rules; each IRB sets its own submission list. Non-significant-risk device studies need no IDE application to FDA; IRB approval and the abbreviated IDE requirements apply. | Confirm with the IRB. | No federal clock. | 21 CFR 56 |
| Canada | Research ethics board (REB) approval covering each site; one REB may cover several sites. | REB approval is required for each site of a drug trial, and for a device investigational testing authorization the REB approval must reference the protocol and consent versions. | Confirm with the REB. | No federal clock. | CTA guidance; ITA guidance |
How many committees review your study?
- One committee per institution. Mexico, Colombia and Peru: each site’s committee reviews. In Mexico the institution’s ethics and research committee can be joined by a biosafety committee.
- One committee for multicenter studies. Brazil: a single CEP, preferably the coordinating center’s, reviews and notifies the other sites’ CEPs (CONEP also reviews special areas under the transitional rules). Chile: one accredited committee reviews and each site carries out a local evaluation.
- Institutional plus national. Uruguay (institutional committee, plus CNEI for trials of new drugs and devices) and the Dominican Republic (site committee, then CONABIOS).
- One national committee. El Salvador (CNEIS).
- Committee, then national registration. Costa Rica (CEC, then CONIS) and Panama (accredited committee, plus RESEGIS registration).
- United States and Canada. One IRB or REB can cover several sites; check the single-IRB rules that apply to your study.
Where each site has its own committee, plan each committee’s calendar separately. Our parallel vs sequential submissions guide covers how committee cadence affects the timeline.
Drugs vs devices
The ethics review asks the same questions for drugs and devices: risks and benefits, consent, participant protection and the team’s qualifications. The technical documents differ. For device trials, the investigator’s brochure is replaced or supplemented by the device description, risk analysis and instructions for use (ISO 14155 sets the international standard for device investigations), and the consent form explains the procedure and the device. In the United States, non-significant-risk device studies need no IDE application to FDA. Some country documents are drug-specific, such as Chile’s ISP file and Colombia’s 2025 committee guide, which is written for studies with medicines. Ask the committee which list applies to a device study.
Ethics submission checklist
- ☐ Protocol, with version number and date, in the local language (and the original where required).
- ☐ Investigator’s brochure (or device equivalent), current version.
- ☐ Informed consent and assent forms in the local language, adapted for the site, with version and date.
- ☐ Recruitment ads, diaries, questionnaires and any material given to participants.
- ☐ CVs and current GCP certificates for the principal investigator and team; medical licenses where asked.
- ☐ Insurance policy or certificate that covers participants in the country, from a local insurer where required. See our insurance requirements by country.
- ☐ Site authorization letter from the institution’s director or legal representative.
- ☐ Contract and budget, where the committee reviews them.
- ☐ Committee forms, declarations of conflicts of interest and proof of fee payment.
- ☐ Apostilled or legalized foreign documents, and official translations, where required.
- ☐ Registration in the national registry (for example Panama’s RESEGIS) where required.
Requirements sponsors often miss
These come straight from the national rules above; each one can send a file back:
- Insurance that names the country. El Salvador asks for a policy that applies in its territory; Ecuador asks for an insurer registered in Ecuador. Our guide on the insurance certificate that starts a device study covers the wording.
- Translations. Ecuador requires an official translation; the Dominican Republic asks for a faithful Spanish translation with the original. See Spanish or Portuguese insurance certificates for ethics.
- Every-page stamping. Guatemala’s consent form must be stamped, signed and dated on every page by the committee president, coordinator or a designated member.
- Investigator credentials. Colombia’s 2025 guide asks for a GCP certificate no older than 3 years; El Salvador asks for GCP certificates for all staff, national and international.
- The sponsor’s home approval. Ecuador asks for the ethics approval from the sponsor’s home country for multicenter trials.
Glossary
- CEI / CEP / CIEI / CEC / CEISH. Local names for a research ethics committee in Mexico and Colombia, Brazil, Peru, Chile and Costa Rica, and Ecuador.
- CONEP / CNEI / CNBI / CNEIS / CONABIOS / CONIS. National ethics bodies in Brazil, Uruguay, Panama, El Salvador, the Dominican Republic and Costa Rica.
- IRB / REB. Institutional review board (United States) and research ethics board (Canada).
- GCP (BPC). Good clinical practice, the ICH E6 standard.
- Apostille. A certificate that authenticates a foreign public document for use in another country.
- Expedited review. A shorter review for minimal-risk studies or minor changes.
Frequently asked questions
What documents does an ethics committee in Latin America require?
The typical packet is the protocol, investigator’s brochure, informed consent form in the local language, recruitment materials, investigator CVs and GCP certificates, an insurance policy (required in most Latin American countries) and the site’s authorization. Countries add their own items, such as the study budget in Colombia or an insurer registered in Ecuador.
Do ethics committees in Latin America charge fees?
It depends on the country. Mexico’s committees do not charge sponsors, and Brazil’s transitional CEP/CONEP rules do not allow committees to charge for review. Panama allows fees, Peru’s committees set their own, and El Salvador’s national committee publishes a fee schedule.
How long does ethics committee approval take in Latin America?
Published clocks run from 10 to 20 business days in Panama and 20 business days in El Salvador to 60 business days in Ecuador; Uruguay’s committees have 60 days. Brazil’s committees have 10 business days to check completeness and 30 business days to give an opinion. Mexico’s national guide recommends no more than 30 calendar days. Colombia and Peru leave the timeline to each committee.
Do documents have to be in Spanish?
Yes for the consent form and participant materials everywhere in Spanish-speaking Latin America, and Portuguese in Brazil. Several countries also want the protocol in Spanish: Mexico, Peru, Ecuador and the Dominican Republic, often with the original. Chile’s regulator file has the protocol in English and Spanish.
Is ethics approval needed before the regulator reviews?
In Mexico, Colombia, Peru, Chile, Costa Rica, Ecuador, Guatemala and El Salvador, yes. In Brazil, and in Panama for high-risk research, the two can run at the same time. In Argentina, ANMAT authorizes the study and each site is then presented with its committee’s approval. See our regulator approval times guide.
Is there a single ethics committee for a multicenter study?
In Brazil, a single CEP reviews a multicenter study and notifies the other sites’ committees. In El Salvador, one national committee reviews. Chile allows one accredited committee plus a local evaluation at each site. In Mexico, Colombia and Peru each site’s committee reviews. In Canada each site needs REB approval, and one REB can cover several sites.
Do device trials need the same ethics documents as drug trials?
The ethics questions are the same, but the technical documents differ: the device description, risk analysis and instructions for use take the place of, or supplement, the investigator’s brochure. In the United States, non-significant-risk device studies need no IDE application to FDA; IRB approval and the abbreviated IDE requirements apply.
Prepare your ethics submissions
bioaccess® prepares ethics packets country by country for drug and device sponsors, and runs the submissions alongside the regulatory file. bioaccess® runs first-in-human studies in Colombia now. Contact us to plan your submissions.
Country walkthroughs: Colombia: IRB (CEI) approval for a device study · Panama CNBI procedure checklist · El Salvador ethics approval · Ecuador ethics approval
Sources
- Argentina: ANMAT Disposition 7516/2025 (InfoLEG).
- Brazil: Law 14,874/2024 (Planalto), Arts. 14 and 58; ClinRegs Brazil (NIH), including the CEP/CONEP rules and the 2026 appointment of INAEP.
- Chile: Supreme Decree 114/2010 (Ley Chile); InvestChile pharmaceutical industry e-book.
- Colombia: INVIMA guide ASS-RSA-GU040 (version 1, December 2025); INVIMA guide ASS-RSA-GU039; Resolution 8430 of 1993.
- Costa Rica: CONIS registration requirements and procedure (2025); CCSS memo CENDEISSS-AB-0115-2024.
- Dominican Republic: CONABIOS operating manual, 2nd edition, submission requirements, and Provision 004-A-2004.
- Ecuador: Ministerial Agreement 00005-2022 (CEISH regulation), Arts. 64, 67, 84, 86 and 87.
- El Salvador: SRS–CNEIS platform user instructions (November 2025); SRS clinical trial evaluation route (2025); CNEIS manual.
- Guatemala: MSPAS Ministerial Agreement 206-2021.
- Mexico: ClinRegs Mexico (NIH), citing the CONBIOÉTICA committee guide (2018); DOF agreements of 28 April 2025 and 4 May 2026.
- Panama: Executive Decree 21 of 2026 (Gaceta Oficial 30510-C).
- Peru: ClinRegs Peru (NIH), citing Supreme Decrees 021-2017-SA and 010-2025-SA.
- Uruguay: Decree 158/019 (IMPO).
- United States: 21 CFR 56 and 812.2 (eCFR).
- Canada: Health Canada CTA and ITA guidance documents.