Consent Forms

Recent changes to the Federal Regulations governing human subject research (the “Common Rule”) have included a focus on improving the readability of consent forms and include regulations requiring understandable language, and organization and presentation of information that facilitates understanding.

In response to these requirements, beginning October 31, 2019, consent forms must satisfy minimum readability standards. We are working on a way to receive proof of PRISM training. Therefore, until further notice, we are not requiring physical proof, but written assurance.

Though we expect to extend the standard to other sections, initially only the readability of the Invitation and Summary section will be assessed.

This section must have Flesch Kincaid reading level ≤8 and Flesch Reading Ease ≥60. Readability may be scored within the RSS application by clicking on the “Readability” button.

CFs not meeting these minimum readability measures will be returned to the investigator for modification.

To assist investigators and their staff in developing necessary skills to write effective consent forms, the PI and the person responsible for writing the consent form, must complete online training through PRISM (Program for Readability in Science and Medicine). The hour-long training covers health literacy and readability, plain language strategies and examples, and interactive editing examples and exercises.

For more information on process, readability standards, and readability tips, see below.

Readability Assessment Process:

Readability Standards:

Tips for writing readable Consent Forms:

Do Do Not
Use short sentences and use words familiar to the non-medical reader. Use medical terminology without explaining it, or use words that an 8th grader would not understand.
Refer to thesauruses and medical glossaries made for children to find alternative ways to refer to medical terminology. Use medical “jargon” or words longer than three syllables, when another word is also appropriate.
Use the second person (“you”) and note that they are asked to participate in a research study. Be personal. Use the third person (“the subject”), and avoid writing “invite” to refer to their participation.
Use pictures and graphs wherever possible. Provide information solely in large blocks of text, with long sentences.
Say “for example” or “so forth.” Say e.g. or etc.
Use tablespoons or teaspoons to refer to the measurement of bodily fluids, and spell them out. Use ml or cc to refer to volumes of bodily fluids, or abbreviate teaspoons/tablespoons.
Say “greater than” or “less than”. Use “>” or “<” or other symbols that an 8th grader might have trouble understanding at first glance.
Describe study terminology such as “randomized”, “placebo”, or “double blind”; such as “like the flip of a coin”. Use medical or study terminology without explaining it in lay terms.
Use the words “study drug” or “study regimen”. Use the terms “therapy” or “treatment” to describe drugs, devices, or procedures.
Refer to investigational drugs or devices as “experimental” or “investigational”, and that it means the FDA has not yet approved it. Refer to investigational drugs or devices as “new.”

Readability Examples and Templates:

UNMC is recommending that study teams utilize the "teach-back" method during the informed consent process for their clinical studies. This method will enhance the informed consent process, ensuring participants are well-prepared before consenting and enrolling in clinical studies.

Our aim is to empower clinical research investigators and coordinators with the tools and knowledge to ensure that research study participants are fully informed and understand all aspects of the informed consent form.

Teach-Back Tool

Ethical Responsibility in Research

The Importance of Health Literacy

"Health literacy plays a crucial role in maintaining a healthy lifestyle and making informed decisions about our health care. Yet, a report from the HHS Surgeon General in 2019 highlighted that only 12% of Americans possess proficient health literacy skills. This underscores the importance of clear communication in the informed consent process."

Reference: HHS Surgeon General Reports and Publications, 2019

The 5 T’s of Teach Back

  1. Triage: Concentrate on one topic at a time.
  2. Tools: Utilize models, written tools, posters, graphics, etc., to aid in explaining the desired information.
  3. Take Responsibility: Phrase it as, “I want to make sure I did a good job explaining…”
  4. Tell Me: Encourage the participant to express their understanding in their own words. Be specific about what you expect them to relay back.
  5. Try Again: If the participant's understanding isn't clear, revisit the topic.

Reference: Anderson, Leister and DeRego, Health Literacy Research and Practice, 2020

Evaluating Understanding with Teach-Back


Revision #19
Created 12 July 2024 18:59:25 by Robert A Lewis
Updated 16 August 2024 16:17:27 by Robert A Lewis