Sponsors from the U.S. and Europe often ask “how do I get IRB approval in Colombia?” The short answer: Colombia doesn’t use “IRB.” Ethics review is handled by a CEI — Comité de Ética en Investigación. The concept is the same as an IRB or EC; the operating rules, timelines, and documentation expectations are not. This is the CEI playbook bioaccess® uses on every medical device study we run in Colombia.
What a CEI is and the legal framework
CEIs are governed primarily by Resolución 8430/1993 (the foundational health research ethics regulation) and the 2024 CEI accreditation rules, which tightened institutional CEI requirements and created a national accreditation registry maintained by INVIMA and the Ministerio de Salud.
Key implications for sponsors:
- Only accredited CEIs can approve interventional device studies. Non-accredited hospital committees can only handle observational/minimal-risk work.
- CEI membership must include a physician, a scientist, a lawyer, a bioethicist, and at least one community representative independent of the institution.
- Sponsors can select an institutional CEI (tied to a hospital) or an independent CEI (freestanding, INVIMA-registered).
Choosing a CEI
For a multi-site FIH device study, a single independent CEI acting for all sites is faster and cleaner than each site’s institutional CEI reviewing in parallel. For a single-site study, the institutional CEI is usually the right choice.
bioaccess® maintains active working relationships with 7 accredited CEIs across Bogotá, Medellín, Bucaramanga, and Barranquilla. Median first-review turnaround across this network: 32 calendar days.
Documents required (13 items)
- Protocol in Spanish (full document + executive summary).
- Investigator’s Brochure, current version.
- Informed Consent Form in Spanish (plus Indigenous-language variants if applicable to the study population).
- Investigator CVs with Colombian medical license numbers (Registro Médico).
- Study budget breakdown, including patient reimbursement.
- Clinical trial insurance certificate (Colombian carrier, per Resolución 2378).
- Sponsor delegation letter authorizing the CRO to submit and manage on behalf of the sponsor.
- CEI fee proof of payment.
- Device labeling in Spanish (mandatory for CEI review).
- Explant / device removal plan (for implantables).
- Post-trial access plan (mandatory under Colombian bioethics guidance).
- Recruitment materials — patient flyers, screening scripts, ads — all in Spanish.
- Data management plan and confidentiality safeguards (Habeas Data Ley 1581/2012 compliance).
Parallel-track strategy with INVIMA
File CEI and INVIMA the same week. INVIMA does not require CEI approval to open evaluation — it requires it before authorizing enrollment. Filing them in parallel compresses total time-to-first-patient-in by 45–60 days versus sequential filing.
Typical CEI review timelines
- First review: 30–45 calendar days from submission to written response.
- Re-review (if stipulations are issued): 15–25 days.
- Amendment review: 20–35 days for substantial amendments.
- Continuing review: Annual, aligned with the study anniversary.
Common CEI stipulations for device studies
Device-specific stipulations that CEIs commonly issue on first review:
- Device labeling in Spanish — required even for imported investigational devices.
- Explant plan — mandatory for implantable devices, must describe device removal at study end or study withdrawal.
- Post-trial access — for devices that benefit the patient, the sponsor must describe continued access mechanism.
- Compensation for injury language in ICF must reference the specific Colombian insurance policy and carrier.
- Community engagement plan — for studies in Indigenous or rural populations.
Ongoing CEI obligations after approval
- Amendments: Substantial amendments filed before implementation.
- SAE notification: 15 calendar days for non-fatal serious events, 7 days for fatal or life-threatening.
- Continuing review: Annual continuing-review report, includes enrollment, safety summary, protocol deviations.
- Close-out: Final study report + database lock evidence.
bioaccess® CEI relationships
bioaccess® has active submission relationships with 7 accredited CEIs: three in Bogotá, two in Medellín, one in Bucaramanga, and one in Barranquilla. Median first-review turnaround: 32 days. Approval rate at first review: 89% over the last 24 months; the remaining 11% received minor stipulations and were re-approved inside 15 days.
Global Trial Accelerators™ coordinates CEI review alongside INVIMA, insurance binding, legal-rep filing, and site contracting under a single accountable operating team.
For a scoped CEI feasibility call, contact bioaccess®.
Leave a Reply