Consent Summary of Key Information

The revised Common Rule requires consent information to “begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” (45 CFR 46.116(a)(5)(i)). FDA’s proposed regulations would add identical language to 21 CFR 50.20. Draft guidance from the Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP), issued in 2024, outlined the elements of key information that should precede the presentation of the full informed consent document.

The UI IRB Consent Summary of Key Information template in HawkIRB contains specific instructions and template language to help UI researchers comply with this regulatory guidance.

This educational tool is provided to offer guidance about different approaches to the consent process, including ways to present key information to potential subjects, and document formatting examples.

Facilitating comprehension in the consent process might include:

Utilizing plain language.
Reading the consent language aloud while the participant follows along and can ask questions.
Asking the participant follow up questions about the information in the consent document.
Offering a video or PowerPoint presentation about the study that the participant can watch and listen to.

Consent Summary of Key Information (pdf)

Plain Language

The guidance recommends following plain language principles for key information section and the entire consent form. (See https://www.plainlanguage.gov/.)

Plain language principles generally involve a combination of text-based and visual approaches (e.g., pictures and diagrams), including

organizing information with the most important points first,
breaking complex information into understandable groups,
using simple language, and
defining technical terms.

Note: The guidance suggests using these formatting options (e.g., bulleted lists, two-column format, white space), could be appropriate for the entire consent form, not just the key information section.

Follow Up Questions

One way that research team members can assist in facilitating understanding is to ask questions to gauge how much the participant has understood after reviewing the consent document. Research has indicated that comprehension is increased if the team member goes through the consent with the participant and then follows up with questions, such as:

“If you were going to tell a friend what this study was about, what would you say?”

“What are the main things that you will do or will happen to you while you are in this study?”

“What are the risks, or bad things that might happen, if you join this study?”

“What are the benefits, or good things that might happen, if you join this study?”

“What can happen if you decide to join the study, but then change your mind?”

Flexible Approaches & Alternative Formats

The regulatory guidance suggests that researchers may utilize alternate platforms (e.g., video, PowerPoint) to help prospective subjects better comprehend the reasons why they might or might not want to participate in research. The use of different formats allows participants who are not as comfortable reading text to engage with audio and video.

Facilitating comprehension in the document might include:

Making sure the grade reading level of the consent matches the targeted population.
Providing charts or other formatting in the document to improve ease of reading.

Reading Level

Information should be presented at a reading level comprehensible to the study population. Explanations should be provided for scientific and medical terms.

An assessment of the needs and characteristics of the prospective subject population, including their age, any relevant medical diagnosis, level of English proficiency, education level, and cognitive abilities, can be helpful in developing consent information that facilitates understanding. Information should be provided in the primary language of a prospective subject with limited English proficiency.

Although not required, one way to evaluate whether the information is presented in a way that facilitates understanding is to have the information reviewed by individuals unfamiliar with the research. This may be particularly helpful for forms translated into additional languages.

Borders, Columns, Charts, and Icons

The guidance recommends organizing information within a defined border (e.g., rounded boxes) creating a discrete unit of information or including charts to make the content easy to read and understand. Other helpful approaches include formatting text into two columns, and/or using bullet points to simplify long explanations (See examples in the Consent Summary for Key Information pdf).

Illustrations or inclusion of icons can also assist the participant with understanding risks or procedures as they read the consent language.

HawkIRB Application Attachments

If using an alternate format to present the key information summary, the IRB must approve what will be presented to subjects in a text version (i.e., transcript of a video).

If utilizing a video,

provide a transcript on a blank stamped template (available in the dropdown menu in the Consent & Assent Document section) and attach it in the “other consent document” section.
If the video is available on a study website, include the hyperlink in Section VII.D.29 and/or VII.D.30.
Attach any other alternative key information materials that cannot contain an IRB approval stamp (e.g., PowerPoint presentation, brochure) in the “miscellaneous attachment” category.