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Informed consent documents for COVID-19 vaccine trials may be too long, difficult to read, and too complex, according to US research. The team systematically evaluated the informed consent documents provided for AstraZeneca, Johnson & Johnson, Moderna, and Pfizer COVID-19 phase III vaccine trials based on length, language complexity, readability, and access to the vaccine for placebo groups if proven safe. In each case, the team found that the informed consent documents were too long, hard to read, and exceed grade 9 in language complexity. Only one of the documents specified that participants in the placebo group might receive the vaccine. They were also able to create a shorter and more readable informed consent document, and recommend researchers hire an editor to collaborate on informed consent documents for future trials.
From:
What The Study Did: Length, readability and complexity of informed consent documents for the COVID-19 vaccine phase III randomized clinical trials were assessed in this quality improvement study.
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