AMDA Foundation - Informed Consent Continues to Raise Questions, Concerns

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Vol XX, Dec `05

Informed Consent Continues to Raise Questions, Concerns

Vol XX, December `05

Informed consent, particularly regarding cognitively impaired residents, is an ongoing challenge and concern for long term care researchers. So it was no surprise that a standing-room-only crowd gathered at the Fall Research Network Conference to hear Jason Karlawish, MD, offer a comprehensive and thought-provoking overview of the subject. Not only did Karlawish's talk result in a lively question and answer period, but several conference participants stayed after the program to further discuss informed consent issues and controversies.

"Informed consent is a voluntary choice of the competent person following an adequate disclosure of the information a reasonable person needs to make a decision", Karlawish stated. "When you suspect that some subjects may have problems making a decision, have a mechanism to assure that people understand what they are doing," he suggested. It is important that the researchers feel certain that subjects understand:

The purpose of the study
Study procedures
How research differs from treatment
Key design features
Study steps and visits
Benefits
Risks/discomforts
Voluntary nature of the study

Understanding involves the ability of the person to comprehend the meaning of the information, Karlawish offered. A common way to help determine that someone has the necessary understanding is to "state the facts and have them state the facts back to you."

Researchers can effectively measure decision-making ability. But first, said Karlawish, "you need to decide what abilities to measure and what the person needs to understand and appreciate to give adequate informed consent."

There are instruments, such as the MacCAT-CR, that can be used to help researchers determine a person's ability to understand and make decisions. "You can decide as a group what standard score is acceptable for study participation," Karlawish added. "If, after the assessment, the person is determined to lack decision-making ability, you either walk away or you find someone who can make the decision for the person."

Karlawish suggested that it might be useful for researchers to define in their protocols who can serve as a proxy. He noted that this definition might include someone who serves or has served as a caregiver to the person, will be available over the course of the study, and serves as a knowledgeable informant to the health care professional. Of course, Karlawish added, "You might decide for some riskier studies that you only want participants who can make their own decisions."

Watch next month's e-newsletter for further information about the MacCAT-CR assessment tool and other issues about informed consent.