Language database makes consent forms consistent

IRBs, researchers can describe risk in lay language

When an institution conducts IRB reviews of hundreds of protocols, it can be hard to maintain consistency on such details as language used in informed consent to describe potential risks and adverse events.

The problem is doubly difficult if, as is the case with the Dana-Farber Cancer Institute, you have seven IRB panels, all with their own standard language.

Researchers are quick to let you know if they're seeing those inconsistencies, says Michele K. Russell-Einhorn, JD, senior director of the Office for Human Research Studies (OHRS) at Dana-Farber in Boston, MA.

"They'll say, 'The last time you made me change the language this way, and now you're making me change it that way,'" Russell-Einhorn says.

So her office has spent the last few years compiling a list of accepted lay language for the description of various risks and events to be included in informed consent documents. The effort has resulted in a searchable database that recently was recognized by the Health Improvement Institute as a best practice in human subjects protection.

Russell-Einhorn and Emily Eldh, assistant director of clinical research for the OHRS, say that while the process of gathering, agreeing on and formatting the language in a searchable way was time-consuming, the result now saves time for both IRBs and researchers who no longer have to extensively negotiate the lay language used in the informed consent.

"If you get a protocol and the investigator just has the risk of 'pneumonitis' listed in the consent document, it will make everybody's life easier if we can say, 'Use our standard language,'" Russell-Einhorn says. "As opposed to saying to the investigator, 'Please rewrite pneumonitis with a lay person's definition,' and he has to go back and write out his idea of what pneumonitis means, and then we have to send it back to the IRB to make sure the IRB agrees that this is acceptable language.

"This really eliminates a step that was slowing everybody down."

Compiling the list

The improvement is more than simply practical — Russell-Einhorn says it's only right that every patient entering a clinical trial at Dana-Farber be exposed to the same information about risks.

"In the world of a cancer center, when you're identifying what you're going to describe as serious and life-threatening and potentially requiring hospitalization, you want to be pretty standard about that, to the extent possible," she says.

Once the problem of inconsistent language was identified, the OHRS began in 2006 compiling lay definitions for various risks as they turned up in protocols.

"We kept Excel spreadsheets for years going into IRB meetings," Russell-Einhorn says. "We wrote down all the different risks and we kept track of the lay language that IRBs asked for."

Eldh says that information was combined with other databases, including the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE).

The third step, Russell-Einhorn says, was to present the information to a regular meeting of the IRB chairs and co-chairs, as well as asking for help from research pharmacists, research nurses and others who could give insight into the best language to use. She and Eldh say they didn't attempt to present the entire list at once, but have introduced language for the most commonly used terms over time.

"One of the only real slowdowns is getting reviewers to review it en masse," Eldh says. "We would set aside time per meeting (of the IRB chairs)."

The OHRS then created the searchable database, which is on its Web site (https://oprs.dfci.harvard.edu/AE/ae_search.asp)

A researcher can type in a term such as "pneumonitis," and turn up the following lay language: "Inflammation of the lungs, which can cause shortness of breath and difficulty breathing. If severe, this can be life threatening." He or she can then use that language in the consent, with the medical term in parentheses afterward, according to Dana-Farber's practice.

The database is always evolving, as new terms get a more thorough discussion and panels come up with improved language for the existing definitions.

Eldh says that a term may come up at an IRB meeting and the panel may ask for a better lay description of it. "We ask the committee (of IRB chairs) how to expand upon it, and try to get that language updated in the database for the next IRB when they have the same question."

Even definitions that have been previously discussed may change as they're discussed

further.

"Once you do something like this, you have to make a commitment to maintain it," Russell-Einhorn says.

She says a key to the project's success has been the collaborative nature of the various IRB panels at Dana-Farber.

"While our IRBs are separate, all of the chairs and key people do a lot of things together for different reasons, so everybody is on the same page," Russell-Einhorn says. "Our primary goal is to make sure that our consents are written in a way that's understandable to subjects.

"The reason this worked was because everybody wanted this to happen."

Even as the database evolves, the OHRS has embarked on a similar project to provide standardized lay language to describe the various drugs used in its clinical trials. Because the same drugs are so often used in different cancer protocols, the institution wants to describe the risks of the drugs in a consistent way.

"One researcher may list 'nausea' as a common risk of a drug in one protocol, while another one might list it as 'occasional' in another protocol," Russell-Einhorn says. "You've got a lot of people taking the same drug on different protocols. One would like to think that all the risks are there, but they're certainly not all described in the same way."

In the meantime, Russell-Einhorn invites other institutions to use their risks and events database, and even make suggested changes to it.

"Our database is available to the public and anyone can use it," she says. "If people see something that needs to be corrected, we would love to hear from them."