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Create an open dialogue to get both
With some complex tasks, it's often easier to break them down into more manageable parts, or to relate them to tasks we are more familiar with. These ideas may prove helpful in designing ways to approach informed consent.
"Informed consent is a process -- a GCP process, and an ethical and legal process," says Linda Wolf , MS, Emerging Markets and Solutions, BBK Worldwide, Newton, MA, at the 44th Annual Drug Information Association meeting in Boston, MA. 1 "Part of what makes up this process is the ability to make informed decisions."
"Coming from a communication background," Wolf says, "one of the first things I ask when we're looking at a study is 'Who are we talking to?' and 'Why are we talking to them?' and 'What is our purpose?'"
Because informed consent is a process, adds Wolf, it's necessarily more than a signature. "There's more than one perspective going into...