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What Should You Know Before Entering a Clinical Trial?

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Charo says many of the answers may already exist somewhere in the consent form, but not in user-friendly language. That's where the layperson's representative on the institutional review board is supposed to help out.

"You cannot use the consent form as a substitute for the consent process. The consent form is simply a piece of documentary evidence that a certain minimum amount of information was made available," she says.

Consent really means ongoing discussions between the patient and the researcher. As mileposts come up along the journey, they need to be fully explained. Such efforts can't prevent every tragedy, but they can improve understanding, which is critical to the research effort, says Charo.

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