In medical research, it is important to receive “informed consent” from participants. This is when participants learn about a study and then agree to participate in it. This ensures that anyone considering joining a research study fully understands the demands, risks and benefits of participating. Often, informed consent documents are long, complex, and hard to understand. As a result, we need to make sure that consent documents are clear and easy to understand for all. Without this, individuals who struggle with literacy and numeracy might not volunteer. This can make a study biased. For example, without these volunteers, the participants may not be like the larger population, so the results may be hard to interpret.

Readability and informed consent

Recently, researchers looked at current informed consent documents from the COVID-19 vaccine trials. They found the documents were very long and complex. In fact, the documents required an average of 35 minutes to read and were above a 9th-grade reading level. They found that it is possible to reduce the length of the documents by more than half. Also, simpler language with a grade 7 or 8 reading level can make the information more accessible.

Importance of health literacy and numeracy

This suggests that COVID-19 vaccine informed consent documents were too long and difficult to read. It is possible to create shorter and simpler informed consent documents for these studies. There are many reasons why minority representation in medical research is low. Researchers need to consider understandability to ensure that individuals are not excluded because of challenges related to health literacy and numeracy.


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