Video Results in Slightly Better Informed Consent, More Satisfaction
When obtaining informed consent from research participants, there is much information to convey and it is not always well understood. “Boilerplate information is sometimes more complex than it needs to be. But you have an important obligation to be sure people can make a thoughtful decision,” says Holly Taylor, PhD, MPH, a research bioethicist in the NIH Clinical Center’s Department of Bioethics.
To date, many interventions to improve research participant understanding of informed consent information have been conducted in simulated research settings. The authors of a recent study tested two approaches used to present information to 273 participants enrolling in six actual studies from 2017-2019.1
“The literature about the ability of any type of informed consent intervention to improve understanding is either slim or inconclusive,” says Taylor, the study’s lead author.
The two interventions tested were a fact sheet and a video showing a conversation between the actual principal investigator and an actor playing the role of the subject. The participants who received the fact sheet did not express better understanding or satisfaction compared to the standard consent form process. Participants recorded slightly better understanding scores if they watched the video vs. the standard consent form process, and also were more satisfied.
“The video was relatively inexpensive to produce. My feeling is that it would be a very worthwhile investment for large clinical trials,” suggests Taylor, who adds that hospital IT departments could help create a video for researchers.
The challenge is to cover all the important information but without needless confusion. An open-ended question can reveal what the person actually understood. Investigators might ask, “When you go home tonight, how are you going to describe the study to your family?” or “When you see a friend tomorrow, how will you explain this trial to them?”
Sometimes, participants talk about how they will personally benefit from the trial. “This gives researchers a chance to correct this misconception,” Taylor notes.
It is an opportunity to explain the individual is unlikely to benefit, but the study might benefit others with the same disease or condition. Taylor says it also is important to keep in mind the person who will be reading a consent form. This is a way to avoid using complex terminology.
“It’s not like writing for the New England Journal of Medicine. It’s like writing for your grandmother,” Taylor says.
REFERENCE
- Taylor HA, Washington D, Wang NY, et al. Randomized comparison of two interventions to enhance understanding during the informed consent process for research. Clin Trials 2021 Apr 23;17407745211009529. doi: 10.1177/17407745211009529.
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