Informed Consent: Procedures, Ethics and Best Practices

Winston Hammond (Editor)

Series: Ethical Issues in the 21st Century
BISAC: MED050000

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Informed consent is in an unsettled state in both bioethics and the law. The central problem in both fields is the absence of a clear, general formulation that supports the kind of information a patient needs in order to make an informed decision. In this book, the absence of a clear, general formulation is the problem chapter one seeks to solve by presenting a theory of informed consent. The following chapter provides a history of translation and interpretation of informed consent in Japan.

Chapter three examines a trend in high court decision making in the United States, Canada, Australia, and the United Kingdom away from a professional standard of disclosure in consent and informed consent to a standard based on what a reasonable person in the patient’s position would want in consent and informed consent. Chapter four focuses on the lack of data about safety and effectiveness, and the research, logistical and legal goals of obtaining consent often conflict with the public health goals of evidence-based shared decision-making.

Chapter five examines informed consent issues in the context of a community collaborative model of service delivery that uses a public health approach. Chapter six provides insight into a novel way to overcome some of these risks when seeking and obtaining informed consent in clinical trials and research. The final chapter evaluates the effect of informed consent format on preoperative anxiety of patients.
(Imprint: Nova)

Preface

Chapter 1
A Theory of Informed Consent: The Information Patients Should Have
(Joseph P. DeMarco and Douglas O. Stewart, Professor Emeritus, Department of Philosophy, Cleveland State University, Cleveland, OH, USA, and others)

Chapter 2
A History of Translation and Interpretation of Informed Consent in Japan: The Reason Why “Japanized” Informed Consent Hurts Patients
(Keiko Sato, Associate Professor, Kyoto University Hospital, Clinical and Institute for Advancement of Clinical and
Translational Science Department of EBM Research)

Chapter 3
High Court Decision Making in Informed Consent: Movement to the Reasonable Person in the Patient’s Position Standard and a Focus on Severe Adverse Outcomes of Low Chance (Probability) of Occurrence
(Dennis J. Mazur, Center for Ethics in Health Care, Oregon Health and Science University, Portland, Oregon, USA)

Chapter 4
The Challenges of Informed Consent when Information and Time are Limited
(Diana Zuckerman, and Christina Silcox, National Center for Health Research, Washington, DC, USA)

Chapter 5
Using A Community Collaborative Model to Address Risk: Ethical, Legal, and Practice Issues Regarding Informed Consent
(Susan Scott, Associate Professor, School of Social Work, Lakehead University Orillia, Canada)

Chapter 6
A Unique Approach to Informed Consent when Undertaking Clinical Research within the Private Practice Setting: Respecting the Patient
(Roy G. Beran, Conjoint Professor, University OF NSW, Professor, School of Medicine, Griffith University, Australia)

Chapter 7
Best Practice in Informed Consent in Oral Surgery
(Aida Gutiérrez-Corrales, Gonzalo Ruiz-de-León-Hernández, Rand Alsheikh, Marisa Heras-Meseguer, Concepción Recio-Lora, Esther Hernández-Pacheco, Daniel Torres-Lagares and José-Luis Gutiérrez-Pérez, Master in Oral Surgery, University of Seville, Seville, Spain)

Index

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