AMDA Foundation - Research Network Meeting Tackles Consent & Other Issues

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Vol XIII, Apr `05

Research Network Meeting Tackles Consent & Other Issues

Vol XIII, Apr `05

The spring meeting of the AMDA Foundation Research Network, held Wednesday, March 16, brought together nearly 75 members to address key challenges facing researchers, plan for future projects, and discuss activities that will facilitate successful research projects. One of the key topics of discussion was informed consent and how this should be handled in long term care facilities, particularly with patients who have some form of dementia. Here are some highlights of that discussion:

Network members discussed the challenges surrounding informed consent and the possibility of developing a standardized way of assessing decision-making capacity. “The view of consent varies. Some say that if a patient says ‘no’ once, don’t ask again,” said Research Network Director Larry Lawhorne, MD, CMD, adding, “Others say that it is acceptable to ask more than once. This variability makes it confusing for researchers--particularly in multi-site studies, which are increasingly common.
A number of instruments have been developed to evaluate decision-making capacity, noted Jiska Cohen-Mansfield, PhD. “My faith in them is limited,” she said. She observed that people can be unable to communicate verbally but “be very specific about what they want or don’t want to do.” There are a lot of “gray areas,” she explained. “Consent is much more than a simple yes or no.”

Consent generally involves a three-step process, said one participant. “Two people who know the patient well say if that person is capable of consenting. Then we conduct a decision-making capacity assessment. Finally, we go to the patient for consent. If the people in the first step say that the patient can’t consent, we go to the proxy,” he offered. However, if the individuals in step one say that the patient should not be involved for any reason, “we don’t pursue it,” he added.

“If the research is low risk,” Cohen-Mansfield noted, “there is no reason not to go to the proxy.” However, she cautioned, “It depends on the type of research being conducted. The risk versus benefit has to be weighed.”

“IRBs would love some sort of standard for consent. Maybe there could be three or four different standards for different types of studies,” said Lawhorne.

“We need to give subjects the best possible opportunity to be involved in the research process according to their capacity,” observed Peter Vasilenko, Chair of the Community Research IRB at Michigan State University. He supported the idea of a standard, noting, “It would be powerful to be able to go to IRBs and say, ‘This is the AMDA standard.’”