Study highlights problems with informed consent docs

Readability should be improved

Investigators too often use informed consent documents that lack the simple language and optimal reading level for communicating information to potential volunteers, an expert says.

"Informed consents are submitted to IRBs, and they're not at the language that patients could understand," says Rebecca K. Schroder, ARNP, MSN, vice chairperson of the institutional review board at the University of Florida in Jacksonville.

"Investigators frequently use medical terminology or language that would be comprehensible at a higher educational level," Schroder says. "This made me curious to see if as an IRB we're being consistent."

So Schroder conducted a study that looked at the readability of informed consent documents and the IRB's own informed consent template.1

The study found that most investigator use language that is close to an 11th grade reading level, according to the Flesch-Kincaid Readability Test that's available on Microsoft Word.1

While the Flesch-Kincaid readability tool has flaws in the context of measuring comprehension, it is a simple and ubiquitous tool that any investigator can use to quickly scan informed consent documents for readability, Schroder notes.

"What Flesch-Kincaid does measure is the number of letters per word and words per sentence and sentences per paragraph," she says. "It's more of a character analysis, but it is a standard."

Schroder also studied the readability of the informed consent documents reviewed by an independent IRB to whom the institution sends its industry-sponsored studies.

"We looked at 50 of those and 50 of the documents reviewed by the local IRB, and they were about the same grade level of readability, which was greater than the 8th grade level," Schroder says.

IRB's own template too complex

Surprisingly, the study also found that the IRB's own template measures at a 9th grade reading level.

"We ask investigators to use language that is at the 8th grade reading level, but we found that our template, which we ask them to put in the informed consent documents, doesn't meet our own standard," Schroder says.

"I was actually surprised by our template findings," Schroder says. "The results were higher than I expected."

The least readable part of the template was the section pertaining to HIPAA, she notes.

"When HIPAA was approved, most institutions incorporated HIPAA language into their research informed consent document," Schroder says. "Half of our informed consent template is related to privacy protection."

The other part of the template includes information about research risks, including who is responsible for paying for medical care related to problems, and what it means for a drug to be approved by the FDA, she explains.

The template has been an evolving document, Schroder notes.

The informed consent document needs to include legal language related to HIPAA and other boilerplate information, but at the same time these sections can be confusing to potential research volunteers, she says.

"It's for the patient's protection to tell them that we may be storing their protected health information in encrypted language or on a secure server," Schroder says. "But on the other hand, we may need to change the wording of that part because a lot of our research patients will have no idea [what this means]."

Investigators who are working to improve the readability of their IC documents also need to keep in mind that it's a process, not a stack of papers for volunteers to read.

"This study looked at IC documents, but it doesn't mean that the investigator isn't speaking to the patient in a language that he or she could understand," Schroder says.

Even so, investigators and IRBs need to work at improving IC documents' readability, because this is what potential volunteers take home with them to read and review, she adds.

"It truly is the investigators who need to make sure that whatever is written in the informed consent document is conveyed to patients in a way that they can understand," Schroder says.

Sometimes investigators will complain that if they bring down the IC document's readability level then it will have the negative consequence of making the IC document longer, she notes.

"The IC documents are 15 pages or more, so if they bring the readability down the concern is that the length of the document will be overwhelming," Schroder explains. "In the 8th grade language it takes us a few more words to convey the same thought."

But investigators shouldn't let this stop them from improving readability, because the overall document will be much simpler to understand, she adds.

"For my next study I'd like to see what we could do to make the IC document better," Schroder says. "I would also like to move into some studies of comprehension because readability does not equate to comprehension."

For instance, Schroder says she would like to conduct surveys of research participants after they've signed the IC document to see what they understood the document to have said.


  1. Schroder RK. Readability of research informed consents and informed consent templates at the University of Florida Jacksonville. Poster presented at the 2007 Annual Public Responsibility In Medicine & Research (PRIM&R) Human Research Protection Programs Conference; Boston, MA: Dec. 1-4, 2007.