Vol XIX, November `05

"Ensuring that relevant staff members are informed and knowledgeable about the study and the process and details of informed consent is time-consuming and difficult," he said. At the same time, he added, "People involved in a study often don't have a shared perception or clear consensus on what needs to be disclosed to subjects and what subjects need to understand to give consent."

Another challenge is establishing and implementing a clear procedure for gaining informed consent from proxies. "A good procedure is necessary to identify these people and work with them. It must address this issue in a way that is both legally and ethically appropriate," said Karlawish.

Determining when an individual is too impaired to consent can be difficult, Karlawish admitted. "It would be inappropriate to say that there is one single cutoff regarding cognition and consent. But we can say that the greater the degree of the impairment, the less capable a subject is of consenting," he noted. For example, Karlawish explained, "An individual with a MMSE [Mini Mental State Examination] score of 0 or 1 clearly isn't going to be able to consent. However, someone with a score of 26-plus probably can." In fact, he suggested, most mild and even moderately impaired individuals generally can give informed consent.

Karlawish shared his expertise on this topic with attendees at the Fall Research Network in Chicago earlier this month. His presentation expanded into a long and lively discussion on this issue; and participants at the Spring Research Network meeting--to be held during AMDA's Annual Symposium in Dallas next March--will hear more about informed consent. In the meantime, watch the next issue of the AMDA Foundation e-Newsletter and the AMDA Foundation Web site for a detailed summary of Karlawish's presentation in Chicago.