Pan American Health Organization · 1st edition, June 2020
Ethical framework for monitored emergency use of unregistered interventions (MEURI) when rigorous trials are not immediately feasible during COVID-19.
- Issuer
- Pan American Health Organization
- Edition
- 1st edition, June 2020
- Audience
- National regulatory authorities, research ethics committees, health care professionals, health authorities
- Evidence
- Expert consensus; application of WHO MEURI framework
- Reviewed
- 19 Oct 2026 · GMJ
What this guideline says
GMJ summary
This guidance establishes an ethical framework for offering unproven COVID-19 interventions outside research settings when randomised controlled trials cannot immediately be initiated. The Monitored Emergency Use of Unregistered and Experimental Interventions (MEURI) framework requires seven criteria: no proven treatment exists; clinical studies cannot start immediately; preliminary safety/efficacy data support use; country authorities and ethics committees approve; adequate resources exist to minimise risks; informed consent is obtained; and use is monitored with results shared promptly.
The document addresses challenges in the Americas where MEURI is often implemented without adequate justification, ethical oversight, informed consent, or data contribution. It emphasises that MEURI is exceptional—unproven interventions should primarily be tested in randomised trials. When MEURI is unavoidable, research ethics committees must review protocols, national regulatory authorities must authorise and monitor use, and all data must be systematically collected and shared to generate evidence whilst protecting patients.
Operational recommendations include developing formal MEURI protocols with scientific justification, population specifications, risk-benefit analysis, data collection plans, and consent procedures. Protocols must be registered distinctively from research trials, reviewed by research ethics committees despite being non-research access, and monitored continuously with mechanisms for modification, suspension, or termination based on emerging evidence.
Key points
For clinicians — doses and thresholds as stated in the guideline
- MEURI is justified only when no proven treatment exists, clinical trials cannot start immediately, and a qualified scientific committee recommends the intervention based on preliminary data showing favourable risk–benefit balance
- Seven mandatory criteria: no proven treatment; trials not immediately possible; preliminary supporting data; approval by national authorities and ethics committee; adequate resources; informed consent; monitored use with data sharing
- Research ethics committees must review and oversee MEURI protocols even though MEURI is defined as access rather than research, ensuring patient protection and data quality
- National regulatory authorities must evaluate, authorise, maintain records, determine reassessment timeframes, and establish supervision mechanisms for all MEURI interventions
- MEURI protocols must specify scientific justification, target population, risks/benefits, data collection plan, consent process, data sharing plan, confidentiality measures, and planned timeframe before transition to formal research
- All MEURI protocols must be registered in clinical trial registries with clear labelling to distinguish them from research protocols, ensuring transparency
- Informed consent must explicitly state the intervention is unproven, may not benefit and may harm patients, with community engagement by health authorities about risks of unproven treatments
- Health professionals managing MEURI have the same obligation as researchers to collect scientifically relevant safety and efficacy data and share findings promptly with national and international scientific communities
Seven Ethical Criteria for MEURI with Categorised Guidance
Table extracted from the guideline
| Criterion | Category | Key Requirements |
|---|---|---|
| No proven effective treatment exists | Justification | High mortality with no proven therapeutic options |
| Clinical studies cannot be initiated immediately | Justification | Must not circumvent trials when feasible |
| Preliminary data support use; scientific committee recommends based on favourable risk–benefit | Justification | Qualified scientific advisory committee assessment required |
| Country authorities and ethics committee approve | Ethical & regulatory oversight | REC and NRA approval required; guided by research ethics principles |
| Adequate resources available to minimise risks | Ethical & regulatory oversight | Only products from good manufacturing practices |
| Patient informed consent obtained | Consent process | Voluntary decision; clear communication intervention unproven; proxy consent as appropriate |
| Use monitored; results documented and shared timely | Evidence generation | Systematic data collection; coordinate with national authorities; aggregate through programmes not single patients |
Source: Pan American Health Organization, Emergency Use of Unproven Interventions Outside of Research: Ethics Guidance for the COVID-19 Pandemic. Reproduced in summary form.
From the guideline
Verbatim
“In the COVID-19 pandemic, unproven interventions should be used in the context of randomized controlled trials that make it possible to assess their safety and efficacy.”
Editor’s perspective
Why this matters for Georgia and the region
Prof. Giorgi Pkhakadze, MD, MPH, PhD
Editor-in-Chief, Georgian Medical Journal · Chair, Public Health Institute of Georgia · WHO consultant, health and migration
As we confront COVID-19 in Georgia and neighbouring countries, this PAHO guidance addresses a tension I have observed: the urgent desire to offer patients potentially beneficial treatments versus the imperative to generate robust evidence through proper trials. Our region's experience with rapid programme implementation—such as Georgia's hepatitis C elimination initiative—demonstrates we can mobilise clinical research infrastructure quickly when political will exists. The most critical recommendation for Georgian clinicians is that MEURI remains exceptional: we must prioritise enrolling patients in properly designed trials like those registered through our national ethics committee rather than offering unproven treatments outside research under the guise of compassionate access. The practical challenge for our context is that implementing MEURI's full framework—scientific committee review, formal ethics oversight, systematic data collection and sharing—requires coordination capacity that may be stretched thin during an emergency, potentially making it simpler and more scientifically valuable to channel those same resources into joining multi-centre trials where infrastructure for data management and safety monitoring already exists.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 19 Oct 2026
Applicability
Georgia and the South Caucasus
For Georgia and the South Caucasus, this guidance addresses a critical gap where unproven COVID-19 treatments may be offered without adequate ethical oversight in resource-constrained settings. National regulatory authorities and research ethics committees in Armenia, Azerbaijan, and Georgia should adapt this framework to local legislation, establishing clear MEURI protocols, registration systems, and coordination mechanisms between ethics committees and health authorities. Given the region’s participation in international COVID-19 research (e.g., Solidarity trial sites), countries should prioritise randomised trials over MEURI, using this framework only when trials genuinely cannot be initiated. Implementation requires capacity-building for research ethics committees to review MEURI protocols rapidly, establishing national registries distinguishing MEURI from research, and developing community engagement strategies to counter misinformation about unproven treatments whilst maintaining public trust in evidence-based medicine.
Questions this guideline answers
Quick answers
What is the difference between MEURI and a compassionate use programme?
MEURI is WHO's ethical framework for emergency use of unproven interventions outside research during public health emergencies. Whilst it may overlap with regulatory concepts like 'compassionate use' or 'expanded access,' MEURI specifically requires seven ethical criteria including scientific committee approval, ethics committee review, systematic data collection, and timely sharing of results to contribute to evidence generation—not merely providing access to individual patients.
Can a research ethics committee review MEURI if it is defined as non-research?
Yes. Although MEURI provides access rather than conducting research, it requires review by a research ethics committee because it involves unproven interventions with unknown risk–benefit profiles, requires similar safeguards to clinical trials (informed consent, monitoring, data collection), and aims to contribute to evidence generation. RECs are best positioned to evaluate patient protection measures.
When should we use MEURI instead of conducting a randomised controlled trial?
MEURI is justified only in exceptional circumstances when it is genuinely not possible to initiate clinical studies immediately. Given that numerous COVID-19 trials have been initiated across the Americas, it is increasingly difficult to argue trials cannot be started. MEURI should not divert resources from needed trials, should be time-limited, and interventions should transition to clinical trials as soon as feasible.
What data must be collected and shared under a MEURI protocol?
MEURI protocols must collect scientifically relevant data providing information on the intervention's safety and efficacy, as defined in coordination with national health authorities. Data must be shared promptly, accurately, and transparently with national and global stakeholders. Close coordination with authorities ensures meaningful data collection without undue burden, preferably through systematic programmes rather than single-patient access.
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- Issuer
- Pan American Health Organization
- Type
- Procedures, manuals, guidelines
- Edition
- 1st edition, June 2020
- Status
- Current
- Published
- 2020-01-01
- Scope
- COVID-19 pandemic
- Audience
- National regulatory authorities, research ethics committees, health care professionals, health authorities
- Licence
- CC BY-NC-SA 3.0 IGO
- Evidence
- Expert consensus; application of WHO MEURI framework
- Record history
- Created 19 Oct 2026 · updated 19 Oct 2026 · next check Apr 2027
Pan American Health Organization. Emergency Use of Unproven Interventions Outside of Research: Ethics Guidance for the COVID-19 Pandemic. Washington, DC: PAHO; 2020. (PAHO/IMS/HSS/COVID-19/20-0024).GMJ Guidelines Library records are original summaries written by the GMJ editorial team from the issuer’s published document and reviewed by a physician. They do not replace the full guideline. The document is the copyright of its issuer and is linked, not hosted. Spotted an error or a newer edition? Tell the Guidelines Desk.
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