IRBs spend considerable time poring over informed consent documents and learning all they can about a study’s informed consent process. But how do these IRB discussions and changes translate into a living informed consent process after the study is approved?
One research nurse who has spoken at national conferences on the topic says that informed consent is complex, especially when the document is based on a sponsor’s template language, which often is written in a way that’s hard for the average person to understand.
“What I’ve learned is it’s very difficult for an IRB to change template language; it’s very difficult for them to simplify that,” says Joy Jurnack, RN, CCRC, CIP, a research nurse with North Shore–LIJ Health System in Great Neck, NY. Jurnack spoke about a research nurse’s perspective on informed consent at the Association of Clinical Research Professionals (ACRP) 2015 Global Conference in Salt Lake City, April 25-28, 2015.
Jurnack views her role as a subject advocate, so she encourages IRBs and researchers to write IC documents at reading levels below high school level.
“I understand how a medical professional views informed consent, and I’m also looking at it through the eyes of the subject,” Jurnack says. “I’m on the front lines, trying to explain the informed consent document to research participants for the IRB, pharmaceutical company or sponsor, and the research site.”
Even college-educated research volunteers will have difficulty understanding an IC document when it is written with medical jargon and legalese, she notes.
“When people walk into a hospital, they’re immediately walking into a stressful situation,” Jurnack explains. “We call it ‘white coat hypertension:’ They see a white coat and their blood pressure goes up.”
These same people will think something is wrong with them when they are enrolled in a clinical trial. They often are sick and have complicated medical issues. Then the research nurse sits with them and has 20 minutes to present the IC document and answer questions, she adds.
Often, the potential volunteer will ask to take the document home with them. This can be problematic when they share it with family members who don’t understand it and were not available during the informed consent process to ask questions about it, Jurnack notes.
“So I try to simplify the document with my words and present it to potential subjects,” she says. “I talk with subjects at length so they understand what’s in the actual document.”
When talking about study procedures, the key is to break it down into simple steps, Jurnack suggests.
For instance, a research nurse or investigator might say, “On screening visit one, you’ll be seen by the medical center staff, have blood drawn, and have blood pressure taken,” Jurnack says. “During the acute phase of the study, you will be required to do this.”
Separating information into one or two sentences makes it easier to explain and easier to follow, she adds.
“Informed consent is a process; it’s not about the signature,” she says. “It’s about continuing to go back to the information to help people understand.”
One area Jurnack refers to continuously is the IC form’s part about how participants can withdraw from the study at any time. Another area she will refer to more than once involves adverse events and the study’s safety profile.
At Jurnack’s first meeting with someone who meets the study’s inclusion criteria, she usually walks into the room with a copy of the informed consent document.
“I wear a lab coat — embossed with ‘Research’ — and a stethoscope,” she says. “I talk about the protocol and why this person qualifies for this research.”
Often, Jurnack will go into details about how the patient’s disease or conditions make him or her eligible to be screened for the study. “Then I talk about how much time is expected of them in the study, and I’ll say that I’m available on my cell phone 24/7 if they have any questions,” she explains.
“If the person’s spouse or significant other is there, I’ll talk with them about their concerns,” she adds.
Jurnack further explains what researchers have learned on the study’s subject and discusses how many people already have been volunteers in the research.
“I say, ‘This is a long document. We can go over it now, or, if not, here’s my business card because I don’t want you to get stuck on something and not be able to ask questions,’” she says.
Jurnack also might speak with the subject’s physician, if that is what the person wants. “So I’m building relationships with both doctors and potential subjects,” she says.
A research volunteer might sign the informed consent document at that first meeting, but that’s not necessary, she adds. “Yesterday a man and his wife were interested in a study, but they’re on their way to Florida, so I’m going to have them come back in a couple of weeks.”
When volunteers take the time to read over the IC form and think about it, Jurnack will have them return for a second meeting to sign the document if they choose to do so.
At the second meeting, she’ll repeat information about any study compensation for participation and the right to withdraw at any time.
“I suggest they bring in the informed consent document at every study visit,” Jurnack says. “I tell them to write notes on the form if they have any questions because it’s very important that they understand what’s going on.”
At a third visit, after the person has enrolled, Jurnack will provide whatever study procedures are necessary and continue to provide informed consent.
“The protocol is a scientific document, and I want the informed consent to be the roadmap that explains to subjects what’s going on,” she says. “The first thing I’ll ask the person is, ‘How have you been? Have you been to the doctor or changed any medication lately?’”
The goal is to encourage the study volunteer to give as much information as possible.
Even as technology is changing the way informed consent can be administered, the IC process needs to be thorough and a shared responsibility between researchers, sponsors, the IRB, and the research nurses who provide informed consent, Jurnack says.
IRBs spend considerable time poring over informed consent documents and learning all they can about a study’s informed consent process. But how do these IRB discussions and changes translate into a living informed consent process after the study is approved?
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