IRB improves consent forms with help from analysts

Avoiding the 'MEGO' syndrome

It's just about a given that informed consent documents making their way to the IRB for approval will need to be revised for comprehension and readability. Investigators and sponsors tend to include long sentences and paragraphs and technical jargon that leads the MEGO syndrome — "my eyes glaze over," says Stewart A. Laidlaw, PhD, an associate vice president for compliance at the Los Angeles Biomedical Research Institute at the Harbor-UCLA Medical Center (LA BioMed) in Torrance, CA.

So IRBs often have to be the ones to simplify the forms, while maintaining the key information. The LA BioMed IRBs have staff analysts who review informed consent documents for readability, style, and substance, Laidlaw says.

"They make sure that nothing that should be left in there is left out, and they make sure it's easily understandable," he adds. "So we have IRB analysts move around paragraphs for clarity and replace technical terms with accepted simplified terms or simplified discussion of it if the technical terms can't be replaced."

The staff analysts also will read the consent forms from the perspective of intelligent, non-scientists, Laidlaw says. While this isn't the IRB staff's only work, they do spend about 25-30% of their time rewriting consent forms, he notes.

"They have the benefit of their many years of experience in reading hundreds of consent forms, and they make acceptable re-organization of words, turning the document into a coherent discussion," he explains.

An investigator can write an informed consent form where everything in it is correct, but it makes no sense because the words are not comprehensible to a nonscientist, Laidlaw says. The narrative might lack order, for instance.

"They may decide after they write the description that they forgot to mention something else, so they slip it into the last paragraph, when, instead, it should be in the beginning of the narrative," Laidlaw says. "Investigators and their staff are busy people."

Investigators who have worked with the IRB in the past know what the IRB wants in an IC form and often will present their documents in that format, so that only tweaking is necessary, Laidlaw says.

"But some investigators have their own perspective of the appropriate way of conveying information, and while it may be perfectly valid, it doesn't conform to the IRB's expectations," he adds. "So there may be some resistance to changing it."

For this reason, the IRB staff analysts work with investigators whenever possible, Laidlaw says.

The staff analysts also work from a template, which is available to investigators through an Intranet Web site. (See sample from informed content template.)

"They use the template and then make sure the IC form's formatting is right and the narrative is right," he explains.

The revised IC form is sent to Laidlaw for his review and signature before it is returned to the investigator.

Once the investigator reviews the changes, the IC document is sent to the IRB reviewer who often might make changes, Laidlaw says.

"The reviewer can make substantive changes, such as saying this risk should be here, and it's not," he explains.

Although the staff analysts' work can add to the time spent on IRB protocol submissions, the IRB has an average five-week turnaround time, Laidlaw says.

"From the receipt of the project in our office to the release of an approval letter is about five calendar weeks, 36 days," he adds.