Pan American Health Organization · 2020
Standard operating procedures for research ethics committees to conduct rapid yet rigorous review of COVID-19 research protocols during the pandemic.
- Issuer
- Pan American Health Organization
- Edition
- 2020
- Audience
- Research ethics committees, institutional review boards, health researchers, research sponsors
- Evidence
- Expert consensus and operational guidance
- Reviewed
- 21 Oct 2026 · GMJ
What this guideline says
GMJ summary
This operational guidance provides research ethics committees (RECs) with template standard operating procedures (SOPs) for rapid ethics review and oversight of COVID-19-related human subjects research during the pandemic. It addresses the urgent need for RECs to maintain rigorous ethical review while adapting procedures to accommodate the tight timelines and volume of COVID-19 research.
The document is structured in three sections: preparation of the REC (composition, member selection, independent consultants, digital systems, and defined responsibilities); the ethics review process (submission procedures, required documentation, review timelines, quorum requirements, virtual meetings, and decision communication); and ethics oversight (remote monitoring and follow-up mechanisms). Key features include 24-hour submission acknowledgment, 72-hour member review deadlines, mandatory inclusion of COVID-19 experts, and virtual or staggered decision-making processes.
The guidance supplements prior PAHO strategies for streamlining ethics review during COVID-19 and provides adaptable templates that RECs can customize to their national context, whether establishing new ad hoc committees or adapting existing institutional RECs to emergency operations.
Key points
For clinicians — doses and thresholds as stated in the guideline
- REC composition must include health experts with COVID-19 knowledge, methodologists, pharmacologists, ethicists, and community representatives with availability for rapid review
- Initial protocol review: documents assigned to at least two primary reviewing members within 24 hours, with 72-hour deadline for member review completion
- Virtual meetings scheduled within 24 hours of receiving member reports; investigators available by electronic means for clarifications
- Amendment and report reviews: 48-hour member review deadline, with REC response communicated to investigator within 24 hours
- Protocol deviations, adverse events, adverse reactions and security issues reported to REC via email within 48 hours of occurrence
- Researchers must respond to REC requests within 48 hours; progress reports submitted according to REC-determined deadlines
- All COVID-19 clinical trials must be registered in a Primary Registry of WHO International Clinical Trials Registry Platform (ICTRP)
- Ethics oversight conducted remotely or deferred with extended deadlines, recognizing rapidly evolving COVID-19 evidence and need to protect REC members and avoid straining health systems
From the guideline
Verbatim
“In this context, research ethics committees (RECs) must be prepared and organized to conduct a thorough ethics review of research, and have rapid and flexible procedures in place to do so efficiently, considering the tight timelines and needs posed by this health emergency.”
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 someone who has worked extensively with WHO on health system strengthening, I recognize that Georgia's research ethics capacity has developed considerably, particularly through our Institute of Public Health's oversight role, but the pandemic revealed gaps in rapid-response mechanisms that persist beyond COVID-19. This PAHO template offers practical solutions that Georgian RECs can implement immediately: the 72-hour primary review timeline with virtual deliberation is achievable even for our smaller institutional committees, and the emphasis on pre-identified expert rosters addresses our recurring challenge of finding appropriately qualified reviewers for specialized studies on short notice. However, Georgian institutions must invest in secure digital infrastructure and train REC secretaries in electronic workflow management—procedural templates alone cannot compensate for inadequate information systems, and our experience shows that rushed ethics review without proper documentation creates liability risks that outlast any emergency.
ORCID 0000-0001-7609-4515 · Perspective written for the GMJ Guidelines Library, 21 Oct 2026
Applicability
Georgia and the South Caucasus
For Georgia and the South Caucasus region, this guidance remains highly relevant for strengthening research ethics infrastructure beyond COVID-19. The region has experienced growth in clinical research participation, particularly in multi-centre international trials, requiring robust and responsive REC systems. The template SOPs can be adapted for rapid ethics review during any public health emergency, including seasonal influenza outbreaks, emerging infectious diseases, or disease elimination research (such as Georgia’s hepatitis C elimination programme). National programmes should consider establishing permanent rapid-review protocols based on these templates, ensuring RECs have pre-identified expert rosters, secure digital platforms for remote review, and clear timelines that balance speed with scientific and ethical rigour. The emphasis on virtual meetings and electronic submission is particularly practical for countries with geographically dispersed research sites.
Questions this guideline answers
Quick answers
What is the maximum time allowed for initial review of a COVID-19 research protocol?
Documents are assigned to at least two reviewing members within 24 hours of receipt. Members have 72 hours to complete their review (may be longer for complex studies). Virtual meetings for deliberation are scheduled within 24 hours of receiving member reports, and decisions are communicated to investigators within 24 hours of adoption.
What additional documents are required for COVID-19 research beyond standard submissions?
A two-page summary in non-technical language, previously published evidence, risk minimization plan to avoid spreading COVID-19 or straining health systems, material transfer agreements, publication and dissemination plans including community result-sharing, and for clinical trials: other REC/regulatory decisions, list of trial centres, and procedures for making effective interventions available to participants and community.
How quickly must adverse events be reported during COVID-19 research?
Reports about protocol deviations, adverse events, adverse reactions and security issues must be presented via email within 48 hours of the events, indicating reasons and measures adopted.
Can REC decisions be made without in-person meetings during the emergency?
Yes. RECs can conduct virtual meetings or use staggered review and decision-making through email and instant messaging. Members who cannot attend virtual meetings can be counted for quorum if they send reviews electronically in advance. Decisions require only the president's signature during the emergency, with countersigning by other members after the emergency ends.
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- Issuer
- Pan American Health Organization
- Type
- Procedures, manuals, guidelines
- Status
- Current
- Published
- 2020-01-01
- Scope
- Standard operating procedures for research ethics committees conducting rapid review of COVID-19-related human subjects research
- Audience
- Research ethics committees, institutional review boards, health researchers, research sponsors
- Licence
- CC BY-NC-SA 3.0 IGO
- Evidence
- Expert consensus and operational guidance
- Record history
- Created 21 Oct 2026 · updated 21 Oct 2026 · next check Apr 2027
Pan American Health Organization. Template and operational guidance for the ethics review and oversight of COVID-19-related research, 15 April 2020. Washington, D.C.: PAHO; 2020. (HSS/BIO/COVID-19/20-0007). Available from: https://iris.paho.org/handle/10665.2/52086GMJ 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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