No one-size-fits-all tool for assessing capacity
No one-size-fits-all tool for assessing capacity
Expert makes these suggestions
When it comes to studying vulnerable populations, investigators and clinical trial staff may have to develop their own tools or adapt existing tools to assess a person’s decision-making capacity to participate in clinical trial research.
The Alzheimer’s Disease Research Center of Washington University in St. Louis has been working on an assessment method that provides an additional protection for human subjects, while also allowing enough flexibility to permit needed research.
"We have been experimenting with an open-ended assessment process where the social worker goes through the informed consent, spends a lot of time with the subject, and asks the subject open-ended questions," says Virginia D. Buckles, PhD, research associate professor, neurology and executive director of the Alzheimer’s Disease Research Center.
The process addresses the main elements of informed consent, all federal guidelines, and touches on the elements of decision-making capacity, especially basic understanding, she says. "We concentrate on the understanding part. We don’t measure all four elements, but we hit understanding and comprehension very hard."
Determining subject’s alertness
For instance, the social worker conducting the assessment will ask nine questions that relate to the main elements of consent. They include these examples:
- Why are you here?
- What will you be doing when you participate in this research with us?
"Then when the person answers, the social worker writes it down verbatim," Buckles says. "Our social workers are highly trained and know when somebody does not understand what’s going on."
Since the center’s studies are longitudinal with some subjects continuing to make visits annually for 25 years, the center also has a short quiz that is used to confirm that a person’s capacity for making decisions continues through follow-up visits, she adds.
"The quiz has true-or-false items and hits on the same information, although it’s a lot easier to administer and score," Buckles explains. "Every year, we review elements of the informed consent, give them a quiz using a criteria requiring they score at least better than chance — 80%."
Each participant has an informant — a spouse, adult child, or a close friend — who is present during the informed consent process but who does not assist with answering the assessment questions, she says.
If the patient loses the capacity to consent, or if the social worker is uncertain about the person’s capacity to consent, then the center may approach a legally authorized representative to make the decision, Buckles explains.
"If someone has a power of attorney in place and they are found to lack decisional capacity, then the power of attorney must make the decision," she says.
The center chiefly assesses potential subjects who may be asked to participate in research and clinical trials for Washington University and outside researchers, Buckles adds. "We recruit the subjects, giving them a diagnosis and assessment; and other investigators ask us for permission to use our pool of subjects, and then we ask the subjects if they want to participate," she explains.
"When we’re running a clinical trial that involves greater than minimal risk, then that increases the importance of the capacity assessment," Buckles says.
Also, when the subjects have moderate or severe dementia, then the center will require a legally authorized representative to sign the consent as well, she notes.
While the center’s process is thorough, some experts in human subjects protection say investigators should not do their own decision-making capacity assessments, and these should be conducted by outsiders, Buckles says.
"But that’s really impractical," she says. "How independent? How do you pay for it? Do they have to be present for each session?"
Nothing about capacity assessment is a black-or-white answer, Buckles notes.
"If someone’s involvement is minimal risk, then we use their individual consent and their study partner is just there as a witness," she says. "But if someone comes in and has suspicions about the study and doesn’t pass the test, then we have to check to see if there’s a power of attorney in place before we can let them participate in research."
When it comes to studying vulnerable populations, investigators and clinical trial staff may have to develop their own tools or adapt existing tools to assess a persons decision-making capacity to participate in clinical trial research.Subscribe Now for Access
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