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Informed consent is more than just a form; it is a process that actively involves the participant. It is an "ongoing exchange of information between the investigator and [participant]" per the OHRP.

A lot has been written about ensuring that the language of informed consent forms is at a level that is easily understandable, and for good reason. The Food and Drug Administration requires all ...

The Revised Common Rule requires all clinical trials to post an unsigned consent form on a publicly available website. The Revised Common Rule is in effect for studies approved on or after January 21, ...

Failure to obtain informed consent can result in significant consequences Exceptions to informed consent apply only in limited circumstances Elements of valid informed consent include patient capacity ...

Informed consent is a process that’s required for most medical procedures. However, there’s often confusion about what informed consent is, what it means, and when it’s needed. In a healthcare setting ...