Making Clinical Research Easier to Understand: New Guidelines for Consent Forms
When people join a clinical research study, it's important that they understand what they're signing up for. But sometimes, the information they receive can be hard to read and confusing. To fix this, a group of experts has come up with new rules to make these documents easier for everyone to understand, especially for those who might have trouble with reading.
Why Is This Important?
Before anyone can join a research study, they need to give their "informed consent." This means they agree to participate after being told all the important details about the study. But if the information is written in a complicated way, it can be hard for people to really understand what they’re agreeing to. This can make them feel unsure or even stop them from joining the study.
To help, experts including doctors, patient advocates, and plain language editors have created a set of guidelines. These guidelines are designed to make the information in research studies clear and easy to read for everyone.
Key Changes to Make Consent Forms Better
The new guidelines focus on five main areas to improve consent forms: Layout, Formatting, Content, Language, and Readability.
Layout: The layout of the documents should be easy on the eyes. Instead of being packed with text, the forms should be organized like a booklet, with enough space between lines and clear, simple images to help explain ideas. The paper should be easy to read on, without too much shine that could make it hard to see the words.
Formatting: The text should use a simple font, like Arial or Verdana, and be big enough to read comfortably. It’s important not to use all capital letters because that can make the words harder to recognize. Headings and subheadings should break up the text so it’s easier to follow.
Language: The language used should be simple and straightforward. Sentences should be short, with no more than 15-20 words. Any difficult words should be explained right away. Instead of long paragraphs, information should be broken into bullet points or numbered lists to make it easier to understand.
Content: The content should be relevant to what the person needs to know to make a good decision about joining the study. The text should use active words, like "Take the medicine twice a day" instead of "The medicine should be taken twice a day." Examples from everyday life should be used to explain difficult ideas.
Readability: Before these forms are used, they should be tested to make sure they are easy to read. This could mean having someone unfamiliar with the study read it or using tools to check if the language is simple enough.
A Big Step Forward
These new guidelines are an important step in making sure everyone can understand the information they receive when they join a research study. By making these forms easier to read, more people can feel confident about participating in research that could help them and others.
The goal is to make clinical research more inclusive and ethical, so everyone has the chance to be involved, no matter their reading level or background. These changes will help make sure that everyone is fully informed and can make the best decision for themselves.
