Ethical oversight in COVID-19: Working with reviewers, a practical guide to help us work together

Do you have questions to our EFGCP Audit and Ethics Working Party Members on how to best handle particular aspects in your studies in today’s situation?
EFGCP provides a weekly opportunity to answer and discuss your questions, free of charge.

This week, Hugh Davies and Heather Sampson both chair Research Ethics Committees reviewing international biomedical and public health research proposals. During a pandemic there are new challenges and opportunities in addition to supporting and overseeing pre-pandemic research.

A few of the research ethics topics to be covered are:

How do research ethics committees review pandemic research differently than pre-COVID-19 studies? How do they manage prioritizing pandemic research proposals?

Can we protect and keep study participants and research teams safe during a pandemic? Is it feasible and practicable in every jurisdiction? (for COVID-19 and non-COVID-19 studies).

Does designing a pandemic ‘work-around’ in clinical trials to accommodate on-line recruitment visits, ‘Zoom’ (or similar technology) medicine reconciliation confirmation, and other tech-based approaches further marginalize vulnerable communities? Will requiring participants to use technology drive down study recruitment?

To reopen, or not to reopen? That is the question. What criteria should be used to make decisions of when to and how to reopen studies that were suspended during COVID-19. Is it safe to open or reopen research during a ‘lockdown’?

When and what criteria are proposed to mandate re-consenting for pre-COVID study participants to continue in their studies? How will these consents be managed? (participant, sponsor, competent authorities, auditors, ethics committees etc.)

How does a pandemic impact privacy and confidentiality, or does it? Should it?