Subscriber Spotlight: Preparing a Readable Consent Form

Modified on March 5, 2026 to remove the “subscribe” option. This blog has been retired and replaced by the S.P.I.R.I.T. newsletter.

Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, and Investigators! 260+ blog subscribers and counting!

I hope everyone is doing well! I can’t believe we are already halfway through 2025. If you’ve been subscribed to the blog from the beginning, you know that I have always promoted collaboration. I love to feature guest authors in my blog.

Check out the collaborative posts that have been published thus far listed below!

• Show and Tell: How to Write a Clear SBER Protocol with Yefrenia Henríquez Taveras, MPH, MHA, CCRP, CHES, CIP, CTP
• ICH GCP E6(R3) vs. E6(R2): Guideline Differences with Adnan Shaikh
• Impact of Immigration Policies on Research and Innovation with Yefrenia Henríquez Taveras, MPH, MHA, CCRP, CHES, CIP, CTP
• Understanding Good Laboratory Practices (GLP) with Neeba Wilson
• Top Tips for Medical Writing vs. Scientific Writing with Adnan Shaikh
• Show and Tell: How to Write a Clear Biomedical Protocol with Yefrenia Henríquez Taveras, MPH, MHA, CCRP, CHES, CIP, CTP

To highlight these contributors moving forward, I have developed a new type of post called “Subscriber Spotlight”.

For these posts, you can expect to see:

• An introduction of the valued subscriber,
• How long the individual has been a subscriber,
• Relevant social media and/or publications, and
• A brief description of what they would like to share with you all!

As a general reminder, these are solely the author’s interpretations (and none of their employer or associated affiliations). Any legal information discussed within this post should be discussed with your institution.

Let’s get started:

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Who is Mila Babaev?

Mila Babaev, CIP has been a loyal subscriber since December 2024. Per her LinkedIn profile:

• She is an IRB and Compliance professional with over a decade of experience supporting Principal Investigators and study teams.
• Further, she is versed in federal, state, and institutional level regulations and policy pertaining to the protection of human‐subjects research.
• She is currently pursuing a Master’s degree in Research Administration and Compliance
  • Her goal is to gain new knowledge from this degree and move into a management role.
• Lastly, she was recently given the opportunity to conduct internal audits/quality reviews on research trials at Atlantic Health System.

Let’s dive into her piece on “Preparing a readable consent form”.

Preparing a readable consent form

Relevant regulatory requirement

In reference to research consent forms, 45 CFR 46.116, requires that:

“The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative.”

• However, many consent forms submitted to the IRBs I have worked for in my 10 years as an IRB administrator contain language which far exceeds the 6th-8th grade recommended language.
• The literature is in line with my experience; a review of written consent forms in 2018 revealed that most are written at a 10th grade reading level or higher across all medical specialties.

Key suggestions to achieve a readable consent form

In my conversations with researchers, it became clear that some do not even realize the terms aren’t in Layman’s terms.

• They are composing and reading the consent through the lens of a scientist/researcher.
• I decided to delve into this topic and discovered a great resource—the Johns Hopkins Informed Consent Guidance-How to Prepare a Readable Consent Form.

The guidance offers two useful ways to detect whether there is an issue with lay language and readability, in general…

1. Read the form out loud to others and gather feedback
2. Check grade level via a word processing tool, such as Microsoft Word

To check the readability via Microsoft Word:

1. On the “File” tab, click the “Options” button
2. Then, on the “Proofing” tab, under “When correcting spelling and grammar in Word”, make sure “Check grammar with spelling” is selected
3. Next, under “When correcting spelling and grammar in Word”, select the “Show readability statistics” check box
4. After the grammar check is complete, Word displays a message box showing you the readability grade-level

This tool can be valuable to researchers as well as IRB members when completing their reviews.

Of course, it would be wonderful to have a tool that pinpoints exactly which words need to be defined in lay terms, so that none are missed. With the current AI wave, I think a tool designed for this purpose can be developed. At present, ChatGPT seems to do a decent job. I copy/pasted all the language in this text up to this point into ChatGPT and posed the question Is any of this language not in lay terms, appropriate for 6th-8th grade reading level? Quite a few responses came up, amongst them “legally authorized representative.”

You can see other key readability tips outlined in the Johns Hopkins article below:

• Use active verbs
• Write concise sentences; You can divide one sentence into two
• Limit each paragraph to one idea
• Keep words to three syllables or less, if possible
• Describe study design procedures such as “double blind,” and “placebo/controlled” at first use

References

1. 45 CFR 46.116
2. Johns Hopkins Informed Consent Guidance-How to Prepare a Readable Consent Form
3. Hadden, K. B., Prince, L. Y., Moore, T. D., James, L. P., Holland, J. R., & Trudeau, C. R. (2017). Improving readability of informed consents for research at an academic medical institution. Journal of Clinical and Translational Science, 1(6), 361–365. doi:10.1017/cts.2017.312

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We hope you found this content useful!

Thank you again, Mila, for your continued support of this blog! Sharing your knowledge with the research and compliance community is truly appreciated. Looking forward to more collaboration with you on human research.