KISS rule: Investigators need to keep it simple
There is no one-size-fits-all model
Researchers still haven't developed the optimal way to give study participants information they want to hear during the informed consent process, an expert says.
"The term that gets used is a one-size-fits-all model, but it's a size that fits none," says David H. Strauss, MD, chairman of the institutional review board at the New York State Psychiatric Institute and director of the office of human subjects research in the department of psychiatry at the College of Physicians and Surgeons at Columbia University in New York, NY.
"We haven't developed methods for providing information during the consent process that are based on what people want or what people need," Strauss says. "They are not really based on any kind of clinical or empirical or common sense approach to providing people with a choice."
Instead, the informed consent document is a recipe containing a regulatory-driven list of criteria. Then there's the addition of institutional risk management considerations, Strauss says.
Sometimes industry-sponsored clinical trials have informed consent documents that have eight to 10 pages describing what happens at every study visit, Strauss says.
"It's a redundant list of physical exams, EKG, blood tests, etc., and it's mind-numbing and distracting from some of the more important issues like alternatives and what it means to be in a study that's placebo-controlled and randomized," he explains.
Also, some of the most important educational disclosures tend to be missing and lose their importance because they're embedded in a consent form that is procedure-heavy, he adds.
"You could describe the study visit once," he says.
It's not necessary to repeat each detail of each visit, so investigators should seek ways to make the descriptions more concise, Strauss says.
"These tend to be what we use to present information to prospective subjects," Strauss says. "So the problem with that is I don't think we do a very good job of emphasizing what's important to somebody who is trying to choose whether or not to take part in a study."
The bottom line is that potential subjects desire information about A, B, and C, and they're given information from E to G.
"There are a lot of factors that contribute to this problem," Strauss says. "For one thing, I think most of us simply aren't very good at conveying information in simple terms."
The typical way investigators convey information to the lay person is by taking the scientific protocol and dumbing it down as they craft the informed consent form, Strauss explains.
"What I encourage investigators to do instead is to write a consent form using language, phrasing, and emphasis the way they might if they were giving a presentation to an advocacy or consumer organization or to a group of medical students," Strauss says.
"In other words, use a conversational tone and non-technical phrasing," he says.
"The other thing we find is that we assume that every subject wants and needs the same amount of information," Strauss says. "And it's not at all clear that we actually expect subjects to retain or use the information we give them."
For instance, Strauss recently reviewed a consent form that was very well written, but it was 13 pages long.
"It's a problem to see a lengthy consent form," he says. "The idea that someone will actually read this and draw information from it when they need to make a decision is far-fetched."
Strauss offers these suggestions for creating a more readable and desirable informed consent form:
1. Provide an outline or overview.
"Some approaches people are talking about involve providing an outline or overview in a simple and brief format," Strauss says.
This could be presented as a single, bulleted cover page that emphasizes the key study points and serves as a guide to what the rest of the consent form includes, he adds.
"It's a preview to coming attractions, but it emphasizes that this part of the study is placebo-controlled, or that it requires inpatient hospitalization," Strauss says. "It includes the things that are likely to be important to someone who is thinking about taking part in a study."
It could be in the format of an overview or summary sheet that tells the subject that this is a guide to the consent form. It would contain the key consent elements and key categories they'd need to see to make a decision, Strauss says.
2. Discuss alternatives.
Informed consent forms tend to emphasize the procedure section and purpose section, Strauss notes.
"It makes sense because the people writing the consent forms know what they have to emphasize and these are the purpose and procedures," he explains. "But what's most important is to explain what the alternatives are."
Potential participants need to know that they can choose to participate in the research or they can consider other options, and those options should be explained in clear details.
"So we've moved the alternative section, which sometimes is buried on page 11 in one little sentence, up to right after the purpose section," Strauss says.
"We show the key procedures in a paragraph and then say, 'You don't have to take part in research in order to receive treatment for your condition,'" he adds.
3. Take on therapeutic misconception idea.
Investigators also can address therapeutic misconception in the informed consent form.
"The subject's inclination is to overestimate the benefit of the study and overestimate the extent to which the study is individualized," Strauss says.
It's important the informed consent document makes it clear to subjects the extent to which they'll derive direct benefit, he says.
In addition to an outline or overview, an informed consent document could provide appendices that offer detailed explanations for people who are interested, Strauss suggests.
Researchers still haven't developed the optimal way to give study participants information they want to hear during the informed consent process, an expert says.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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