Dedicated editors help a research program manage an informed consent library of terms that can be included in consent forms as a substitute for medical/scientific language.
“With help from the editors, we have come up with some well-crafted consents,” says Sam Briggs, protocol activation manager at Memorial Sloan Kettering Cancer Center (MSKCC) in New York City.
MSKCC created the consent library as part of its performance improvement project that resulted in the launch of a centralized protocol activation core (PAC), which includes Briggs and seven other protocol activation managers, and two dedicated editors.
“We thought that if we looked at the set of consents approved since our unit rolled out, we could basically lift the language we like from all IRB-approved consents and turn it into a library,” Briggs says. “It’s important to have a good system of standards.”
The consent library is available electronically on a shared drive, he says. “One thing we want to do over the coming months is find a way to make it more accessible to investigators and primary study teams,” Briggs adds. “We’d provide training for study teams on how to use it, and what the expectations are.”
They built the consent library, starting with risks, converting complex terms like anemia into layman’s terms, he explains.
For example, the risk of anemia could be described as “low red blood cell count,” which better describes the condition in layman’s terms. “All lab conditions have scientific terms,” Briggs says.
Words and terms describing procedures also can be put into simpler language or explained, he adds. “The most complicated part of it is drug mechanisms,” he says.
Although MSKCC’s studies are varied, there are overlapping features. For instance, immunotherapy might be used in different types of research, so this was an important word to describe for the consent library.
“Immunotherapy is a big category, and it was important to us to set a definition and put that into the consent library,” Briggs says. “It saves activation managers’ time, and saves IRBs’ time.”
Immunotherapy drugs are common. The PAC worked with a pharmaceutical company to create a risk section for the drug, he says. “That’s one way we made this more efficient,” Briggs adds. “We have that whole section to put into the consent form.”
The consent library is designed as a spreadsheet. The left column lists the scientific names of informed consent terms, including adverse events.
For example, the library lists the scientific term “adrenal insufficiency” in the first (A) column to the left. The other columns are:
• Column B. This is the language the editor approved to describe the scientific term. For adrenal insufficiency, the editor approved text is “Decreased production of hormones by the adrenal glands, located on top of each kidney; symptoms may include dizziness, irritability, fainting, low blood pressure, skin darkening, and craving of salty foods (approved date: 02212019).”
• Column C. Notes/keywords: “Kidney, hormone.”
• Column D. Description 1: “Adrenal glands (glands on top of the kidneys) may not make enough hormone, causing tiredness; weight loss; muscle weakness; feeling faint; joint, muscle, and abdominal aches; nausea; vomiting; loose or watery stools; fever; salt craving; and sometimes darkening of the skin like a suntan.”
• Column E. Description 2: “Decreased production of adrenal hormones, which can cause weakness and/or low blood pressure.”
• Column F. Description 3: “Decreased production of hormones by the adrenal glands, located on top of each kidney; symptoms may include dizziness, irritability, fainting, low blood pressure, skin darkening, and craving of salty foods.”1
“We add new words to the library in batches,” Briggs says. “Once a month or so, I’ll go back and look at the approved consents for the past month and make sure all risk terms and procedures are in the consent library.”
For instance, Briggs recently looked at a dose escalation, stage one study. “I worked closely with the editor to come up with a clear way to describe that to participants, and we put that into the library,” he says. “The next time any of the nine activation managers come across [a similar study], it will save them time to just go to the library, pull it out, and tell the sponsor that this is the way we’ve decided to describe the term.”
Sponsors rarely question these changes, Briggs notes. “The overall goal is to find ways to be as clear as we can for participants, and to keep the bar high in quality of these consent forms,” he says. “These editors do an amazing job making sure these are clear, readable, and consistent.”
Protection activation managers and editors share access to the library. The editors read through consent forms, looking for words that research participants might have trouble understanding.
“For a word like anemia, we want them to say exactly what anemia is: ‘a low level of red blood cells,’” Briggs explains. That description can be used in future consent forms this way: “anemia, which is a low level of red blood cells.”
Typically, the description would be listed once. But if the word “anemia” is used again in the informed consent form, then the description would not need to be repeated, Briggs says.
The consent library now includes 400-500 words, and is growing, he adds.
Another group at MSK is developing an e-consent platform for patients that they could access on tablets. “They’ll complete the consent form and check boxes as needed,” Briggs explains. “We see, in the future, having a method to type in some kind of short-word language that pulls directly from the consent library to the e-consent.”
They could put a hashtag before the word, such as “#anemia,” and this would be an efficient way to add the editor-approved language to consent forms, he adds.