This workshop examines the draft ‘International Recommendations for Ethics Committees (IECs/IRBs) When Reviewing Vaccine Clinical Trials During Public Health Emergencies’.

These draft recommendations were developed with funding from the World Health Organization to support the work of the Health Ethics & Governance Unit and PHEPREN (the Public Health Emergency and Response Ethics Network, which the unit initiated) in the call for proposals on ‘The Ethics of Public Health Emergency Preparedness and Response’ (published October 9, 2020).

Here is a link to the current version of the Draft Recommendations: ‘Recommendations for Ethics Committees (IECs/IRBs) When Reviewing Vaccine Clinical Trials During Public Health Emergencies’.
Please feel free to download the document to comment and suggest edits before Wednesday, March 24 2021. Your edits can be sent to Francis P. Crawley (fpc@gcpalliance.org).

The workshop brings together experts in ethics review, vaccine development, regulatory oversight, and patient and community involvement to evaluate the draft recommendations and consider their best routes for implementation. Significant time will be devoted to discussion between the summary presentations.

Monday, March 22, 2021, 14:00 to 16:00 CET

Panellists

• Introduction: How strengthening national ethics review systems and ethics committees promotes confidence in vaccine clinical trials and COVID-19 vaccines

Dr. Amadou Diadié Maïga, African Vaccine Regulatory Forum (AVAREF) & Regional Vaccine Regulatory Officer at the African Regional Office (AFRO), World Health Organization

• From capacity building to capacity sharing: Building ethics and trust into vaccine research
  Francis P. Crawley, COVID-19 Clinical Research Coalition, Ethics Working Group; Good Clinical Practice Alliance – Europe (GCPA) & Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Leuven, Belgium
• A critical appreciation of the draft recommendations from a national and global perspective
  Professor Perihan Elif Ekmekci, Head, History of Medicine and Ethics Department; Head, IRB; Member, Open Science Committee; Deputy Dean, Medical School TOBB ETÜ, Ankara, Turkey (10 minutes)
• Why vaccine developers need competent ethics review for vaccine clinical trials during COVID-19 and other public health emergencies
  Professor Anna P. Durbin, Center for Global Health, Johns Hopkins Vaccine Initiative, and Member, Institutional Review Board, Johns Hopkins Bloomberg School of Public Health, USA
• The role, remit, and function of ethics committees in society during a public health emergency
  Professor Sarah JL Edwards, COVID-19 Clinical Research Coalition, Ethics Working Group; Professor of Bioethics, Department of Science and Technology Studies (STS) University College London, United Kingdom
• How improved ethics review can contribute to equity in research and access to vaccines during the current COVID-19 pandemic and regarding future public health emergencies
  Elissa Prichep, Project Lead Precision Medicine, World Economic Forum
• Summary of the International Workshop and Next Steps
  Professor Haihong Zhang, Office Director, Peking University Human Research Protection Program, Peking University Health Science Center, Beijing, China

Concept Note

Download the document

Recording

Watch the workshop

Organizers

Good Clinical Practice Alliance (GCPA)