Informed consent disclosure to vaccine trial subjects of risk of COVID?19 vaccines worsening clinical disease

“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.”

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7645850/