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Thursday, March 19, 2015

Enduring and Emerging Challenges of Informed Consent

Christine Grady, Ph.D.
N Engl J Med 2015; 372:855-862
February 26, 2015
DOI: 10.1056/NEJMra1411250

Here is an excerpt:

A substantial body of literature corroborates a considerable gap between the practice of informed consent and its theoretical construct or intended goals and indicates many unresolved conceptual and practical questions.  Empirical evidence shows variation in the type and level of detail of information disclosed, in patient or research-participant understanding of the information, and in how their decisions are influenced.  Physicians receive little training regarding the practice of informed consent, are pressed for time and by competing demands, and often misinterpret the requirements and legal standards. Patients often have meager comprehension of the risks and alternatives of offered surgical or medical treatments, and their decisions are driven more by trust in their doctor or by deference to authority than by the information provided. Informed consent for research is more tightly regulated and detailed, yet research consent forms continue to increase in length, complexity, and incorporation of legal language, making them less likely to be read or understood. Studies also show that research participants have deficits in their understanding of study information, particularly of research methods such as randomization.

The entire article is here.