Balanced ethics review : a guide for institutional review board members /: a guide for institutional review board members. (2016)

• Record Type: Book
• Further Information: Note: Simon N. Whitney.
• Authors: Whitney, Simon N
• 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 IRB 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 Consent Forms -- 5.3 Presenting Risk and Benefit -- 5.4 Subject Understanding -- 5.4.1 Less is More -- 5.4.2 Ethical Considerations -- 5.5 Supervising Consent Form Writing -- 5.5.1 Helping the Investigator -- 5.5.2 Readability -- 5.5.3 Format -- 5.6 Editing the Consent Form -- Chapter 6. The Social Sciences -- 6.1 The Value of Dissent -- 6.2 The Social Impact of Research -- 6.3 Freedom of Speech -- 6.4 Psychology -- 6.4.1 Deception -- 6.4.2 Threats to Self-Esteem -- 6.5 Surveys and Interviews -- 6.5.1 Risk and Benefit -- 6.5.2 Modifications -- 6.6 Field Research -- 6.6.1 Risk -- 6.6.2 The Sociologists' Dispute -- 6.7 Racial Discrimination.- Chapter 7. Biomedical Research Topics -- 7.1 Archival Research -- 7.1.1 Cancer of the Vagina -- 7.1.2 Regulatory Oversight -- 7.1.3 Ethical Considerations -- 7.1.4 The Common Rule -- 7.1.5 HIPAA -- 7.2 The Learning Health Care System -- 7.2.1 Integrating Research and Clinical Care -- 7.2.2 Ethical Considerations -- 7.2.3 Your IRB's Role -- 7.3 Randomized Controlled Trials -- 7.3.1 Risks Inside and Outside of a Trial -- 7.3.2 Nonphysical Risks -- 7.4 Comparative Effectiveness Trials -- 7.4.1 Identifying the Better Treatment -- 7.4.2 Faden's Bold Ethical Proposal -- 7.4. Waiver of Consent in Special Circumstances -- 7.5 Justice -- 7.5.1 Unjust Burdens -- 7.5.2 The Governmental Pursuit of Justice -- 7.5.3 The Private Pursuit of Justice -- 7.6 The Vulnerable -- 7.6.1 Regulatory Overprotection -- 7.6.2 Fighting Health Disparities -- 7.7 Paying Subjects -- 7.7.1 Respecting Subject Choice -- 7.7.2 Coercion -- 7.7.3 Setting a Cap on Wages.- 7.8 Emergency Research -- 7.8.1 Criteria for Approval.- 7.8.2 Ethical Considerations -- 7.9 Phase 1 Cancer Trials.- Chapter 8. FDA and OHRP -- 8.1 Agencies under Pressure -- 8.2 Your IRB and the Agencies -- 8.2.1 Balancing Three Goals -- 8.2.2 When Regulations Trump Ethics -- 8.2.3 The Successful IRB -- 8.2.4 Things Can Go Wrong -- 8.3 Pushing Back against Federal Pressure -- 8.3.1 The Agency -- 8.3.2 The Funder -- 8.3.3 The Media -- 8.3.4 The Courts -- 8.4 Risk and your IRB -- Chapter 9. The Future -- 9.1 Evidence -- 9.2 Reform -- 9.3 The Challenge -- References -- Index.
• Publisher Details: Cham : Springer
• Publication Date: 2016
• Extent: 1 online resource
• Subjects: 174.2; Social sciences; Medical ethics; Medicine -- Research -- Moral and ethical aspects; Human experimentation in medicine -- Moral and ethical aspects; Institutional review boards (Medicine); BUSINESS & ECONOMICS / Business Ethics; Human experimentation in medicine -- Moral and ethical aspects; Institutional review boards (Medicine); Medical ethics; Medicine -- Research -- Moral and ethical aspects; Human Experimentation -- ethics; Ethics Committees, Research; Medical -- Epidemiology; Medical -- Public Health; Medical -- Psychiatry -- General; Epidemiology & medical statistics; Public health & preventive medicine; Psychiatry; Anthropology; Epidemiology; Psychiatry; Social Science -- Anthropology -- General; Anthropology; United States; Electronic books; Electronic books; Handbooks
• Languages: English
• ISBNs: 9783319207056; 3319207059; 3319207040; 9783319207049
• Related ISBNs: 9783319207049
• Notes: Note: Includes bibliographical references and index.; Note: Online resource; title from PDF title page (EBSCO, viewed November 5, 2015)
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.