The decline and fall of informed consent

Over at KevinMD there’s a great post by Richard Gunderman (Chancellor’s Professor, Indiana University) and James Lynch (Dean of Admissions, University of Florida College of Medicine). In the post they authors bemoan the fact that informed consent documents have become impenetrable aggregations of legalese in comprehensible to almost everyone.

However, the authors only hint at the most important point. Informed consent is the mutual understanding arrived at between two entities. Informed consent may be guided by the massive document to which the authors refer. The document may be used to memorialize the agreement. But, the document is not the agreement.

The authors refer to a 30+ page “informed consent” document for a cancer study. The average person would find the document entirely incomprehensible. But, the average person might actually sign the document because (s)he believes  that the study might offer improved opportunity for survival. The belief is frequently without merit.

Patient have a right to question the care they receive. In particular they should question experimental care. The most important thing any patient should realize-

The purpose of research is NOT to improve your health. The purpose of research is to advance medical knowledge and possibly the career of your physician.

Medical researchers have an irremediable conflict of interest and this conflict of interest will not be in the “informed consent” document. But this conflict of interest may well compromise your health and safety.