Informed consent disclosure to vaccine trial subjects of risk of COVID-19 vaccines worsening clinical disease
March 2021 | Authors: | PubMed | Source
“Conclusions drawn from the study and clinical implications: The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.”
Emanuel EJ, Boyle CW. Assessment of Length and Readability of Informed Consent Documents for COVID-19 Vaccine Trials. JAMA Netw Open. 2021 Apr 1;4(4):e2110843. doi: 10.1001/jamanetworkopen.2021.10843. PMID: 33909052; PMCID: PMC8082317.
“Importance: Informed consent is a fundamental element of research ethics. The COVID-19 vaccine trials are high profile trials that have enrolled more than 100 000 participants. Consent documents must be succinct and understandable to ensure informed voluntary participation.”