Aging strategies call for 'reformed consent'
Aging strategies call for 'reformed consent'
Media changes, so should IC process
Written informed consent will exist in human subjects research for as long as regulations require it, but this doesn't mean IRBs and investigators are stuck within its limitations.
"The paper consent is problematic, to say the least," says Dilip V. Jeste, MD, an Estelle and Edgar Levi chair in aging and director of the Sam and Rose Stein Institute for Research on Aging at the University of California in San Diego. Jeste also is a distinguished professor of psychiatry and neurosciences at UCSD.
Paper informed consent forms have uniformity, but it's not clear whether people reading these have any real understanding of what they're signing, Jeste says.
One way researchers could help potential study participants better understand the IC document is by presenting it in a slide show with narrative, he suggests.
"We published a paper of a controlled trial using slides versus paper consent, and we found the people seeing the slides consent did significantly better in terms of understanding the consent," Jeste says. "We asked people a series of questions, and those who saw the slides had a better comprehension than those who saw the paper consent form."
But even a slide presentation has limitations, he notes.
"So we thought the next step should be to present informed consent information in a way that would mirror the experience subjects would have in a trial," Jeste explains.
For example, a trial that requires an MRI might include a video in the IC process that shows how an MRI is done and how loud and claustrophobic it might be to some participants, he says.
Learning theory has shown that people process information both verbally and visually, so any educational information that incorporates these two learning processes would be more effective than singling out one of the two processes.
In the MRI example, if an investigator showed potential subjects the video and then supplemented the visual presentation with an explanation of why it's necessary and how it might be uncomfortable, the subjects would have a better idea of what to expect and might be less likely to drop out of the study, Jeste says.
"This gives a person a much better idea of what we mean, and at the end we'll have better comprehension," Jeste says.
Multimedia preferred
In a recent study about reformed consent and using new media, such as a 20-minute DVD, in the IC process, Jeste and investigators found that subjects preferred including multimedia tools in the IC process.1
Most participants also were interested in accessing the Internet and contacting prior study participants during the IC process.1
Of 30 men and women participating, 24 indicated a preference for video-aided consent; five had no preference, and one person liked the written consent better.1
DVDs can be played on a computer in a research office or given to potential participants for viewing in their own homes, Jeste notes.
For the study, researchers told participants they could stop the DVD at any time to ask questions, and they could control the speed at which the DVD was shown, he says.
"The DVD was designed for one specific study for a drug that improves cognition, a hypothetical drug that was based on similar, existing drugs," Jeste explains.
Written informed consent will exist in human subjects research for as long as regulations require it, but this doesn't mean IRBs and investigators are stuck within its limitations.Subscribe Now for Access
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