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Key Information in the New Common Rule: Can It Save Research Consent?

Published online by Cambridge University Press:  01 January 2021

Nancy M. P. King
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Abstract

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 2: Human Subject Protection , Summer 2019 , pp. 203 - 212
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

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