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Expert outlines main struggles, solutions to better informed consent
Get rid of one-size-fits-all notion
Most principal investigators (PIs) are not very good at conveying complex ideas in simple terms, an IRB and research expert says.
"My experience is that investigators tend to begin with a scientific protocol and then try to dumb it down in order to craft the consent form," 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, department of psychiatry, College of Physicians and Surgeons at Columbia University in New York City.
"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, they should use a conversational tone and nontechnical phrasing."
IRBs sometimes make a mistake of thinking that certain models or standardized informed consent forms are the solution to creating comprehensive and simple informed consent (IC) forms.
"The term that gets used is one-size-fits-all model — a size that fits none," Strauss says. "We haven't developed methods for providing information during consent that are based on what people want or what people need."
When institutions create an IC template, it's rarely based on empirical evidence of what potential participants need to know and how they need to learn it.
"Instead, what we see is a regulatory-driven list of criteria and a format," Strauss says. "Then added to that are a whole series of institutional risk management considerations."
The problem with this approach is that it doesn't do a good job of emphasizing what's important to a person who is trying to decide whether or not to take part in a study, he adds.
"We tend to not match the informational needs of prospective subjects to the information we provide," Strauss explains.
"The other thing we find is that we assume that every subject wants and needs the same amount of information," Strauss says. "It's not at all clear what we actually expect subjects to retain or use of the information we give them."
For example, Strauss recently reviewed a 13-page IC form.
"It's common to see a lengthy consent form," he says. "But the idea that someone will actually read this and draw from it what they need to make a decision is farfetched."
Strauss offers these additional suggestions for improving IC forms:
• Provide an outline: One useful approach to improving the clarity of an informed consent form is to provide an outline or overview in a simple and brief format, Strauss suggests.
This could be a single page with bullet points emphasizing the key study points, he says.
"Essentially, it serves as a guide to what the rest of the consent form includes and is a preview to coming attractions," Strauss says.
For instance, the bullet points could emphasize that a study is placebo-controlled or that it requires an inpatient hospitalization, he says.
"It includes some of the things that are likely to be important to someone who is thinking about taking part in the study," Strauss says.
• Discuss alternatives to research: Research participants need to know what the alternative treatments are to what is provided in the research study. This section might be titled, "What are my options?"
And it needs to be placed more prominently in the IC document, not buried in a small paragraph on page 11, Strauss says.
"Move it up so it occurs right after the purpose," Strauss says. "Put the key procedures in the paragraph, and then say that the person doesn't have to take part in research in order to receive treatment for his or her condition."
Also, if a study is a nontreatment study, the study should make this clear to participants, and the alternatives section is a good place to emphasize this point, he adds.
• Clarify personal benefits: Therapeutic misconception is very common among research participants, and this partly might be due to the IC document overestimating a study's benefits to individual participants, Strauss notes.