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By Melinda Young
The revised Common Rule charged IRBs with writing concise and focused informed consent information. The challenge for IRBs is how to achieve this.
The Colorado Multiple IRB (COMIRB) at the University of Colorado has found a novel solution. The IRB trained staff on how to write key information consistently. They also added these tasks to the IRB staff’s workload without delaying IRB reviews, or having to use additional staff resources.1
“It started with IRB leadership writing key information,” says John C. Heldens, RAC, CIP, director of COMIRB at the University of Colorado Denver Anschutz Medical Campus. “Once we set our boundaries and decided what would be included in key information, and what would be excluded, we documented those as an internal guidance document. We trained IRB managers, who train IRB staff, to read the consent form, look at the protocol, and draft a key information system.”
The process was time-consuming at first, but has become easier and faster, he notes. “The goal is to keep it short, to one page,” Heldens says. “By and large, we have achieved that.”
Another chief goal was to keep the information meaningful, providing the subject with a high-level summary to read before perusing the entire informed consent document.
“When they read the first page, they have a pretty good idea of what the study is about,” he says. “There are more details in the rest of the informed consent form, but we think this change has been successful.”
Consistency is a third major goal. “We also felt that consistency was important,” Heldens says. “I’m not sure it’s critical, but whether we have a consent form from oncology, cardiology ... key information is consistent.”
This is how the IRB created the key information page:
• Engage IRB staff, chairs, and campus leaders. The IRB’s professional staff created the key information with input from IRB chairs and campus leadership, he says.
IRBs review thousands of consent forms, so they can rely on their experience and expertise in writing or approving a key information page, Heldens notes.
“There’s a learning curve, but it’s not as steep as you might think,” he says. “We also asked for input from IRB community members for the project. We wanted feedback from previous patients and research participants.”
• Include relevant and essential information. The key information includes a preamble that describes the study. It also should include brief sections on the study’s purpose, procedures, risks, benefits, and alternatives.
“We made a change to our consent form to put the principal investigator’s contact information on the first page,” Heldens says. “We didn’t have that number listed before, but we considered who people would go to for questions on the key information. We addressed that by putting the investigator’s number on the front page.”
Key information includes a broad description of procedures. “In the context of a clinical trial, there may be dozens of screening procedures, and we don’t describe all of those,” Heldens explains. “We say, ‘You’ll have a screening visit, and if you’re eligible, this is what will happen.’ But we don’t describe the fairly routine procedures.”
The description of procedures might look like this: “First, you have a screening visit. Second, if you’re eligible, you might be assigned to one or two visits,” he says.
“We don’t go into details about screening visits,” Heldens adds. “What we want to do is get to the point right away.”
• Summarize risks. The idea is to summarize overall risks, as opposed to breaking down the risks by drugs or devices.
“List the most important risks, which are the ones that are serious or common,” Heldens says.
If death is a risk, it is part of key information. “You could have a page of risks for each drug in oncology research,” Heldens says. “Those risks are identical from study to study, so we made a good effort to summarize the risks.” Sometimes, it might be appropriate to break out risks by a drug or device, but that can be part of the decision-making process, he adds.
They also decided that costs are not part of the key risk information, unless there is something in the trial that will significantly increase a participant’s cost, Heldens says.
“We also decided that confidentiality is never part of the key information because it’s never a real risk,” he explains. “By and large, investigators do a good job of protecting confidentiality, so it’s rarely a real risk of subjects.”
• Include benefits and alternatives. “These typically are a boilerplate statement that participating in the study involves studying a treatment and a person may or may not benefit by participating in research,” Heldens says.
“If the study is not intended to benefit the subject, then we say that,” he adds. “We keep this section short.”
Alternatives to participating in the study are listed, if any.
• Describe randomization. The key information page informs participants that they might or might not receive the experimental drug or device. The decision is made randomly, Heldens says.
“We say, ‘You’ll be assigned to one of the following two groups, and you don’t get to decide,’” he explains. “If the study is blinded, then you won’t know which group you’re in.”
In describing randomization, the key information emphasizes that the study participant does not have a choice on whether they receive the experimental treatment.
• Describe the scope of study the activity. “We will summarize the number of visits and how long you’ll be in the study,” Heldens says. “We may say, ‘You will have 12 visits over three years,’ and we’ll have a couple of sentences about what those visits entail, although we don’t go into details of the visits.”
More information is given later in the document. “We make exceptions when they are unusual visits,” Heldens says. “If a population that wouldn’t otherwise have a CT scan is going to have a CT scan, we’ll say, ‘You’ll have a CT scan and be exposed to radiation.’”
Or, if the study population typically would undergo one MRI or CT scan, but the study calls for three MRIs or CT scans, that is included in the key information, he adds.
• Select writers. The COMIRB piggybacks the writing of key information to the IRB staff’s normal workflow.
“When a study comes in, one member of the staff is in charge of prescreening, and is required to become familiar with the study,” Heldens explains. “That person sticks with the submission from the beginning until it’s approved.”
This person is a natural fit for writing the key information because the coordinator already knows the study application well, he adds.
New IRB coordinators are not asked to perform this task. Their managers will write it for them, he says. “Teaching people to write key information takes time,” Heldens notes. “If they know how to edit and are familiar with the consent form, they can pick sentences off of it.”
The writers also need to learn how to summarize. When they have finished the first draft of a key information page, the IRB manager will review it and provide feedback.
“The manager will sit down with them, showing them templates and guidance, and go over that information, giving them real case examples,” Heldens says. “They don’t practice on fake studies; they practice on real submissions in real time. The managers know how to do this very well, so feedback is and editing are quick.”
• Obtain feedback. Initially, investigators wanted to know why they need that key information page. But over time, they came to accept it, Heldens says.
“There are some study teams that, after they got a few examples, started writing it themselves. There’s no problem with that,” he says.
The IRB staff found it interesting to try something new that involved using their creativity, he notes.
“I practiced a number of these, and I found it rewarding,” Heldens says. “It’s an activity we don’t always get involved in, and it’s different between editing and writing.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.