Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research

November 3, 2020

Lynch, H. F., Bateman-House, A., & Joffe, S.

Annals of internal medicine

Choosing between the standard of care treatment and emergency use authorization (EUA) therapies is a matter of deeper roots than legality. During these times of crisis where the world has been forced to find new ways of fixing all kinds of problems, the FDA has given its open approval for treatment therapies that are still missing more studying but seem to be safe enough to be considered viable healthcare alternatives. Right from the early surge of the pandemic, the WHO put out general guidelines for clinical decision making, yet this new option may lead both doctors and patients to a place of uncertainty and moral distress. The authors state how, perhaps, the “trials only” stipulation on EUAs use could help generate more evidence and set a common ground between evidence-based medicine, offering the patients the best treatment plan possible and patient’s informed consent along with autonomy.

Lynch HF, Bateman-House A, Joffe S. Emergency Approvals for COVID-19: Evolving Impact on Obligations to Patients in Clinical Care and Research [published online ahead of print, 2020 Nov 3]. Ann Intern Med. 2020;M20-6703. doi:10.7326/M20-6703

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