Informed Consent: What Must Be Disclosed and What Must Be Understood? (Joseph Millum and Danielle Bromwich).
ABSTRACT
Over the last few decades, multiple studies have examined the understanding of participants in clinical research. They show variable and often poor understanding of key elements of disclosure, such as expected risks and the experimental nature of treatments. Did the participants in these studies give valid consent? According to the standard view of informed consent they did not. The standard view holds that the recipient of consent has a duty to disclose certain information to the profferer of consent because valid consent requires that information to be understood. The contents of the understanding and disclosure requirements are therefore conceptually linked. In this paper, we argue that the standard view is mistaken. The disclosure and understanding requirements have distinct grounds tied to two different ways in which a token of consent can be rendered invalid. Analysis of these grounds allows us to derive the contents of the two requirements. It also implies that it is sometimes permissible to enroll willing participants who have not understood everything that they ought to be told about their clinical trials.
Why Have Uniform Informed Consent Documents When the Research Volunteers Are So Diverse? (Ross E McKinney Jr)
Informed Consent, Understanding, and Trust (David B Resnik)
When Does Nudging Represent Fraudulent Disclosure? (Derek Soled, Neal W Dickert and Jennifer Blumenthal-Barby)
Varieties of Minimalism about Informed Consent (Gopal Sreenivasan)
The Grounds of the Disclosure Requirement for Informed Consent (Tom Dougherty)
Promoting Disclosure and Understanding in Informed Consent: Optimizing the Impact of the Common Rule ‘Key Information’ Requirement (Kathryn M Porter, Elliott M Weiss and Stephanie A Kraft)
Utilizing Community Research Committees to Improve the Informed Consent Process (Philip G Day, David Satin, Robert P Lennon and Marc Tunzi)
Informed Consent Conversations: Neither the Beginning nor the End (Barclay R Rogers and Liza-Marie Johnson)
€€€€€€€€€€€€€€€
The American Journal of Bioethics Volume 21, Issue 5 (2021)
First posted 2021-05-05 12:30:50
Leave a Reply