Informed consent helps form the bedrock of all clinical research. The most typical way of obtaining informed consent is via a written document, called the informed consent form (ICF), which the prospective participant reads and, if willing to participate, signs.
The US Code of Federal Regulations lays out several general requirements for obtaining informed consent. Prospective participants must be given “sufficient detail” about the research project, “organized and presented in a way that…facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.”
Thus, ICFs should be highly readable and well-organized while containing enough details about the research to allow for an informed decision.
How does this work in practice? Let’s look at the state of things.
Current State of ICFs
Emanuel & Boyle (2021) evaluated the ICFs of four large randomized controlled trials (enrolling over 100,000 patients) for readability and length.
On average, the ICFs were 22 pages long, requiring about 35 minutes to read for an average adult (48 minutes for adults with poorer reading ability). Of the average 8300 words, over 35% of the ICF text detailed risks and privacy concerns. The average reading grade level of the ICFs was 10th grade, which is two grades higher than the maximum recommended reading level (8th grade) for such documents.
Why are these documents so complicated? One idea posed by Emanuel & Boyle (2021) is that there may be a desire to prioritize “liability mitigation over participants’ comprehension.” Their recommendation? To avoid “leaving the creation of informed consent documents to [stakeholders] whose expertise is not careful, succinct writing.”
Balancing the huge amount of information and complicated medical and legal terminology often found in ICFs with the need to create readable, well-organized documents is a tricky task. However, applying the tenets of “plain language” may be one route for developing better ICFs.
The Idea of “Plain Language”
Per the Plain Writing Act of 2010, plain language is “writing that is clear, concise, well-organized, and follows other best practices appropriate to the subject or field and intended audience.” Congress passed the Plain Writing Act to make it easier for U.S. citizens to access and understand government documents.
As outlined on the PlainLanguage.gov website, developing documents in plain language means focusing on the reader’s (audience’s) needs. For example, is your document organized in such a way that the average reader can:
- identify key information (readable),
- understand that information on the first read (understandable), and
- use that information to meet their needs (actionable)?
The same principles easily apply to ICFs:
- Readable: Clearly highlight the key information your prospective participant needs to know.
- Understandable: Ensure that information is not too complex and can be comprehended by the average prospective participant.
- Actionable: Provide enough information so that your prospective participant can make an informed decision about whether to participate in the research study.
Thus, following the guidance on the PlainLanguage.gov website (including the Federal Plain Language Guidelines [2011]) can help us create better ICFs and improve the overall informed consent process.
4 Tips for Simplifying Your ICFs
1. “Use Lots of Useful Headings”
Headings can help organize your document and break your content into smaller, easier-to-digest pieces, but not all headings are equally effective. The guidelines identify three types of headings: the Topic heading, the Statement heading, and the Question heading. See each heading type in action:
- Topic heading: “Purpose” – Straightforward, but not very meaningful.
- Statement heading: “Purpose of this Research” – More specific and more meaningful.
- Question heading: “What is the Purpose of this Research?” – Mirrors the question your reader may be asking.
The guidelines recommend using Statement and Question headings wherever possible.
2. “Use Pronouns to Speak Directly to Readers”
Don’t be afraid to use “you.” Using “you” in your ICF makes the document feel more relevant to the reader and makes their responsibilities in the research easier to understand. See this example:
- “Participants will return to the clinic for a follow-up visit.”
- “You will return to the clinic for a follow-up visit.”
3. “Minimize Abbreviations”
Use too many abbreviations, and you might lose your reader. Abbreviations that are second nature to people in the industry (like PI and IRB) are likely meaningless to your prospective participant.
True, you can define these terms on first use: “The principal investigator (PI) will contact you if…” but with so much information to get through, it may be hard for the reader to commit all these new acronyms to memory.
The solution? Nicknames.
For example, after first use:
- Refer to the Institutional Review Board as “the Board.”
- Refer to the Principal Investigator as “the Investigator.”
4. “Use Short, Simple Words”
You can typically improve the readability of your ICF by replacing longer words with shorter ones, “jargony” words with familiar ones, and roundabout phrases with straightforward ones.
- Long vs. Short
- …may terminate the trial…
- …may stop the trial…
- Jargony vs. Familiar
- …will receive the intervention…
- …will receive the treatment…
- Roundabout vs. Straightforward
Side note: Sometimes, words are just not easily replaceable – think lists of side effects or possible medical adverse events. In that case, consider adding simple-to-understand definitions for medical terms, like “hematoma (a bruise)” or “myocardial infarction (a heart attack).”
Conclusion
The Federal Plain Language Guidelines (2011) offer many more great ideas for improving ICFs. We’ll be back with more tips, as well as a discussion of the evidence on how plain language impacts the ICF process.
References
- Emanuel, E. J., Boyle, C. W. (2021). Assessment of length and readability of informed consent documents for COVID-19 vaccine trials. JAMA Netw Open, 4(4), e2110843.
- Plain Writing Act of 2010. Pub. L. No. 111-274, 124 Stat. 2861 (Link)
- Federal Plain Language Guidelines (2011), Rev. 1 (Link)
