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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645850/
Informed consent disclosure to vaccine trial subjects of risk of COVID©19 vaccines worsening clinical disease
3. CONCLUSION
Given the strong evidence that ADE is a non©theoretical and compelling risk for COVID©19 vaccines and the ¡°laundry list¡± nature of informed consents, disclosure of the specific risk of worsened COVID©19 disease from vaccination calls for a specific, separate, informed consent form and demonstration of patient comprehension in order to meet medical ethics standards. The informed consent process for ongoing COVID©19 vaccine trials does not appear to meet this standard. While the COVID©19 global health emergency justifies accelerated vaccine trials of candidates with known liabilities, such an acceleration is not inconsistent with additional attention paid to heightened informed consent procedures specific to COVID©19 vaccine risks.