Table 2. Examples of Informed Consent Language and Potential Simplifications.
| Document section | Original | Potential simplification | ||||||
|---|---|---|---|---|---|---|---|---|
| Text | Length, words, No. | Grade level | Readability scorea | Text | Length, words, No. | Grade level | Readability scorea | |
| Purpose | Coronaviruses are a large family of viruses that cause illness ranging from the common cold to more severe disease, such as Middle eastern respiratory syndrome and SARS-CoV. Coronaviruses are zoonotic, meaning they are transmitted between animals and people. An outbreak of COVID-19 caused by the 2019 novel coronavirus SAFr-CoV-2 began in Wuhan, Hubei Province China in December 2019 and has spread throughout China and to over 200 other countries and territories, including the United States. There is currently no vaccine that has been shown to be effective against SARS-CoV-2. Therefore there is an urgent public health need for rapid development of novel interventions to prevent the spread of this disease. This study is testing mRNA-1273 study vaccine at a dose of 100 μg. The main purpose of this study is to understand if MrNA-1273 can prevent COVID-19 and to understand the safety of the mRNA study vaccine | 146 | 12.4 | 43.1 | This study will test a vaccine against the virus that causes COVID-19. | 12 | 6.8 | 67.8 |
| Risk | As in all research studies, the COVID-19 vaccines may involve risks that might be expected based on results from studies of similar vaccines, as well as risks that are currently unknown | 31 | 14.4 | 47.1 | This vaccine may cause currently unknown risks. | 7 | 5.7 | 66.8 |
| Pregnancy protections | The study doctor will discuss with you the methods of birth control that you should use while you are in this research study and will help you select the method(s) that is appropriate for you. The study doctor will also check that you understand how to use the birth control method and may review this with you at each of your research study visits | 65 | 13.1 | 59.3 | The study doctor will help you choose and implement an effective method(s) of birth control. | 16 | 8.4 | 61.9 |
a
Range, 0 to 100, with 100 indicating easiest to read and scores less than 60 considered difficult by the Department of Health and Human Services.