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Keep informed consent interactive, avoid therapy misconception
Think "process" not "paper"
Clinical research (CR) sites that work with hospitalized, critically-ill adults face special challenges in handling the informed consent process.
For one thing, this is a population whose cognitive status can be impaired by both disease and treatment while they're in the intensive care unit (ICU), says Cindy Munro, PhD, RN, ANP, SAAN, a professor in adult health and nursing systems at Virginia Commonwealth University in Richmond, VA.
"The problem is that if you ask them anything that requires recall, their memory of events during their hospital stay is often less than perfect," Munro says.
Recent studies have suggested that many clinical trial participants have difficulty retaining some basic information about the study in which they are enrolled.
For instance, one study of long-term clinical trials found that less than one-third of 789 participants who were asked at their final follow-up visit what the main side effect of the study drug was could answer the question.1
These same participants, who had been enrolled in the study for five years were also asked what the study's purpose was and what was the name of the medication under investigation.1
The study showed that 64.7% of participants correctly reported the study's purpose, and 79.6% knew the drug's name.1
Older participants had more difficulty recalling the three main details about the study, the study showed.1
The findings suggest that CR professionals need to improve the informed consent process, particularly when participants are older and critically ill.
They also need to make certain consent is properly obtained in the cases of impaired or critically ill subjects.
"In our research we always have gotten the consent of legally-authorized representatives," Munro says.
The state of Virginia has clear guidelines about how legally-authorized representatives for research might be used, Munro adds.
"The other thing we do is because our patients can't either verbally or in writing provide their consent, we look at their behavior," she adds. "If they shake their head that they don't want to participate, then we'll respect that too."
If patients are sedated, research staff will get the legally-authorized representative involved, Munro says.
"To the extent we can, we involve the patient," she adds.
Other strategies for improving the informed consent process include making the informed consent document more readable, Munro suggests.
"You can use appendices rather than putting all the information in this dense packet," Munro says.
"One strategy that seems to have the best results is having an extended informed consent discussion," she adds. "The longer you spend answering patients' questions and reviewing the material, the better their recall will be."
The ongoing model of informed consent works best, Munro says.
"I would like to see investigators rely less on the signature on the form and rely more on patients' understanding of the process," Munro adds. "I do think the simpler the consent form, the more well-organized it is, then patients will read the central information, and it would be helpful."
There isn't a one-size-fits-all when it comes to informed consent. So some strategies that might work well for one population could be a bad idea for another one.
For instance, providing subjects with CDs of consent and trial information might be a very good strategy for a population of media-savvy participants, but not so great for others.
Good news, bad news
The good news is that investigators in general are more attuned to informed consent issues now than they have been in the past, Munro says.
The bad news is that they still struggle with their own therapeutic misconceptions about studies, she says.
"If you didn't have some belief in the treatment, you wouldn't do the study," Munro notes. "It's difficult when providers are not just providers, but also are investigators."
The human subjects research industry has had difficulty dealing with this issue, she says.
"If your provider is telling you, 'I'm doing this research study, and let me tell you about it,' there's some lingering thought in your mind that he wouldn't be asking you to do this if it wasn't good for you,'" Munro says.
Munro handles therapeutic misconception by separating her care provisions and research. "I don't work in any of the intensive care units where my studies are being conducted," she says.
A prohibition against dual roles would be too complicated for research institutions to enforce. But some sensitivity is needed, Munro says.
"You need to be aware of roles that have friction between them," she suggests. "And if investigators are sensitive to that they can make an extra effort to separate their roles when with patients and subjects."
For example, during the informed consent process, an investigator should explain that the study will not provide the participant with any therapeutic benefit, repeating what is in the informed consent document, Munro says.
"Investigators have to be careful of the way in which this information is presented," she adds. "Investigators need to be seen as the researcher and not the care provider in that interaction."
If a physician is having a first conversation with a patient about a research study, then the introductory comment might begin this way: "In addition to being your provider, I also do research in the area of your disease. The research I do may not have a direct benefit to you, but the research may help us learn how to treat people better in the future," Munro suggests.
So the best overall informed consent approach is to keep it interactive, Munro says.
"The written informed consent form has to pretty clearly communicate and standalone and be enhanced by the consent discussion," she adds.