DOWNLOAD
— Guidance
English, Spanish, Portuguese, French
— Summary
English, Spanish, Portuguese, French
— Recommendations
for health authorities:
for research ethics committees:
— Publication's PPT presentations
— Accreditation tool for RECS
(incorporates lessons from the guidance)
English, Spanish, Portuguese, French
Research is an essential component of public health emergency preparedness and response. Therefore, it is essential to be able to carry out research as soon as a health emergency begins and to ensure that it is carried out in an ethical manner.
This Pan American Health Organization publication provides direction for strategies and guidelines on modifying ethical oversight processes in emergency situations, ethically monitoring ongoing research in the face of new evidence, and overcoming other ethical challenges that arise when doing research in public health emergencies. It also provides guidance so that the emergency use of unproven interventions outside of a research setting is carried out in an ethical manner. Finally, it includes the lessons learned in the Region of the Americas during the COVID-19 pandemic and recommendations resulting from a regional reflection exercise aimed at improving ethical preparation for conducting research during future health emergencies.
Inputs for the Publication
Previous Publications
- Ethics guidance on issues raised by the novel coronavirus disease (COVID-19) pandemic (March 2020 / Published by PAHO in Spanish)
- Guidance and strategies to streamline ethics review and oversight of COVID-19 related research (April 2020 / Published by PAHO in Spanish)
- Operational guidance and template for the ethics review and oversight of COVID-19-related research (April 2020 / Published by PAHO in Spanish)
- Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO, May 2020 / Published by PAHO in Spanish)
- Emergency Use of Unproven Interventions Outside of Research. Ethics Guidance for the COVID-19 Pandemic (June 2020 / Published by PAHO in Spanish)
- How Can Research Transparency Be Promoted? Actions for National Health Authorities During the COVID-19 Pandemic (September 2020 / Published by PAHO in Spanish)
- Guidance for ethics oversight of COVID-19 research in response to emerging evidence (November 2020 / Published by PAHO in Spanish)
Regional Dialogues
Virtual seminar series on topics related to clinical trials
- Ethical preparedness for research in emergencies (June 12, 2026)
- Adaptive and platform trials (May 6, 2026)
- PAHO Clinical Trial Accelerator (April 9, 2026)
- Ethics of human challenge studies (March 2, 2026)
- Artificial intelligence and ethics review of research: challenges and opportunities (Dec. 2, 2025)
- Rethinking the concept of vulnerability in research (Nov. 7, 2025)
- Clinical trials on advanced therapies (Oct. 21, 2025)
- Regional template for clinical trial agreement (Aug. 26, 2025)
- Ethical inclusion of pregnant participants in clinical trials (Aug. 13, 2025)
- Pre-approved protocols for clinical trials: Importance and pending challenges (June 18, 2025)
- Template for clinical trial contract and insurance policy: regional proposal (June 4, 2025)
- How to promote more and better clinical trials in Latin America and the Caribbean? (May 6, 2025)
- New guideline for Good Clinical Practice: E6(R3) (March 18, 2025)
- Why and how to promote collaboration in health research? (Feb 27, 2025)
- Research contracts and insurance policies for clinical trials: Regional challenges (Dec. 05, 2024)
- Research integrity and responsible conduct of research (Nov. 14, 2024)
- Clinical trial registration and the International Clinical Trials Registry Platform (ICTRP) (Oct. 9, 2024)
- Challenges of adaptive trials (Sep. 25, 2024)
- The U.S. single IRB policy: challenges and lessons (Aug. 30, 2024)
- Data Monitoring Committees (DMCs) and the role of ethics (Jul. 17, 2024)
- Animal research and the role of committees for the care and use of animals (Jun. 12, 2024)
Challenges and lessons to be learned in Latin America and the Caribbean: Regional dialogues on research ethics during the pandemic (2020-2021)
- Strategies for ethics review and oversight of research during the pandemic
- REC Procedures (No English translation available)
- Social and scientific value, and informed consent
- The perspective of researchers
- The risk-benefit assessment of studies
- What have we learned so far?
Indicators for strengthening national research ethics systems: Series of regional sessions (2021)
- PAHO’s indicators for strengthening national research ethics systems
- Regional assessment using the indicators: Achievements and pending challenges
- Regional assessment of the indicator on research in emergencies: Progress during the pandemic
Catalyzing ethical research in emergencies: Regional dialogues on the lessons learned from the COVID-19 pandemic and pending agenda (2022)
- Reflection and discussion on the preliminary recommendations
- Presentation of the revised recommendations and pending agenda