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Balanced Ethics Review|Simon N. Whitney

Balanced Ethics Review : A Guide for Institutional Review Board Members

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Overview

Table of Contents Title Page Dedication Preface Acknowledgements Chapter 1. Introduction 1.1 Overview 1.2 Ethics and the IRB 1.3 IRB Process 1.4 Evaluating Biomedical Research 1.5 Consent in Biomedical Research 1.6 The Social Sciences 1.7 Biomedical Research Topics 1.8 FDA and OHRP 1.9 The Future Chapter 2. Ethics and the IRB 2.1 Your Influential Position 2.2 Evidence 2.3 Scandal 2.4 Research Ethics 2.4.1 Two Ethical Principles 2.4.2 Two Ethical Goals 2.4.3 Goals into Practice 2.4.4 Today's Loss of Balance 2.4.5 It's Always about People 2.5 Ethical Goals and Regulatory Means 2.5.1 Principles of Regulation 2.5.2 Organization and Legal Framework 2.6 Your IRB Service 2.6.1 Compensation 2.6.2 Protection from Lawsuits 2.6.3 The Community Member 2.7 The Triumph of Ethics Review Chapter 3. IRB Process 3.1 Principles 3.1.1 Respectfulness 3.1.2 Transparency 3.1.3 Efficiency 3.1.4 Clarity 3.1.5 Accountability 3.1.6 Judiciousness 3.1.7 Rationality 3.1.8 Restraint 3.2 The Curse of Power 3.2.1 Scope of IR B Authority 3.2.2 Litigation Prevention 3.2.3 Beyond the Regulations Chapter 4. Evaluating Biomedical Research 4.1 The Objective IRB 4.1.1 Ramsey and the Scientist's Bias 4.1.2 Your Reasonable Understanding 4.2 Literature Reviews 4.2.1 Death at Johns Hopkins 4.2.2 Reviews by Investigators 4.2.3 Reviews by IRBs 4.3 Ethics and Science 4.3.1 Scientific Modifications 4.3.2 The Value of Research 4.3.3 Risk 4.4 Weighing Risks, Benefits, and Knowledge 4.4.1 Why You Should Protect Subjects 4.4.2 Why You Should Let Subjects Choose 4.4.3 The Conundrum 4.5 Approval Based on Risk and Benefit 4.5.1 Established Theories 4.5.2 Rajczi and Meyer: Let the Subjects Decide 4.6 Consent before Approval Chapter 5. Consent in Biomedical Research 5.1 Consent's Goals 5.2 Multisite Co

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Details

  • ISBN-13: 9783319207049
  • ISBN-10: 3319207040
  • Publisher: Springer
  • Publish Date: November 2015
  • Dimensions: 8 x 5 x 0.35 inches
  • Shipping Weight: 0.38 pounds
  • Page Count: 131

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