Medical Risk and the Right to an Informed Consent in Clinical Care and Clinical Research

Author: Dennis J. Mazur, MD, PhD

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Medical Risk and the Right to an Informed Consent in Clinical Care and Clinical Research

Here is chapter and verse on the role and rules of informed consent in both patient care and clinical research. The book provides an extensive and enlightening legal history of informed consent and specific guidelines for implementation of meaningful and successful informed consent processes. Most important, the book carefully relates informed consent to issues of medical quality and risk management.

183 Pages © 1998

Table of Contents

Part One
Medical Risk and Informed Consent in Clinical Care

Chapter 1
Development of the Informed Consent Doctrine Related to Clinical Care

Chapter 2
Medical Risk and Informed Consent in Clinical Care

Chapter 3
Professional Standard of Disclosure (1767-1990)

Chapter 4
The Reasonable Person Standard (1972-Present)

Chapter 5
The Reasonable Person Standard in Canada

Chapter 6
Patient Informedness: Interaction between the Reasonable Person Standard, State Statute, and State Supreme Court Decision Making

Chapter 7
Ethical Perspectives in Informed Consent: A Patient-Centered Formulation

Chapter 8
Cognitive Perspectives: How Information Is Disclosed

Chapter 9
Decisional Capacity: From "Ranking Harms" to "Weighing Risk and Benefit"

Chapter 10
Optimizing Patient Informedness and Shared Decision Making: Whose Responsibility?

Part Two
Medical Risk and Informed Consent in Clinical Research

Chapter 11
Development of Informed Consent in Human Subject Research

Chapter 12
Clinical Research: The Business of Institutional Review Boards

Chapter 13
Informing Patients about Potential Participation in Medical Research Involving Human Subjects

Chapter 14
Challenges and Controversies in Evaluation of Clinical Research in Human Subjects

Chapter 15
Physicians' Accessibility to the Information They Need for Decision Making and for Informing Patients

Chapter 16
Summary and Conclusion