Balanced Ethics Review

Simon N. Whitney, MD, JDAssociate Professor and William O’Donnell and Regina O’Donnell Chair in Family MedicineDepartment of Family and Community MedicineAssociate Professor, Center for Medical Ethics and Health PolicyBaylor College of MedicineHouston, TXUSA.

• 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.- Chapter9. The Future.- 9.1 Evidence.- 9.2 Reform.- 9.3 The Challenge.- References.- Index.

"The aim of this pocketbook-size manual is to assist Institutional Review Board (IRB) members and chairs to conduct ethics reviews by balancing the two major morally relevant considerations in health research ... . The book is written in easy-to-read language and would be understandable to all members of the IRB, including the lay member." (Ames Dhai, South African Journal of International Affairs, Vol. 9 (2), November, 2016) "This would be an extremely valuable read for future researchers in preparation of their research proposals and planning ethical issues which may present significant hurdles, particularly within the ever changing UK research ethics landscape ... . I found this book interesting, insightful and instructive for both a researcher and an ethics reviewer/board member. I thoroughly enjoyed reviewing this book." (Julie Hoole, British Journal of Oral and Maxillofacial Surgery, Vol. 54 (9), November, 2016) "Simon Whitney's book is seasoned with a wealth of examples from US IRBs ('Institutional Review Boards'), many of the examples will be of interest to non-American readers as well. ... Whitney's book provided a very good basis for evaluating my own work at an ethics board, notwithstanding some differences, and it would provide a fantastic basis for discussion at a yearly, reflective retreat that every ethics board should have." (Ulrich Teucher, British Journal of Psychology, October, 2016) "Dr. Whitney has put together a small guide for those who are contemplating joining the IRB ... . I found this guide to be a very useful read, even after many years of service on a local IRB. I believe that this manual is an indispensable introductory text for anyone considering serving on the IRB. It will certainly help both junior and more senior faculty members decide whether or not to accept the offer to join the IRB." (Richard Balon, Academic Psychiatry, October, 2016) "Balanced Ethics Review is intended to be a guide for members of Institutional Review Boards ... those interdisciplinary committees that are tasked with reviewing the ethical probity of research involving human participants. ... Balanced Ethics Review: A Guide for Institutional Review Board Members is an insightful exposition of the 'curse of power' tantalizing IRBS." (T. Christie, Current Oncology, Vol. 23 (5), October, 2016) "It is written from within the American review system. But by openly discussing the difficulties of balancing ethical values, and by bringing to the fore how research ethics functions as 'balance ethics,' the book has greater universality." (Par Segerdahl, The Ethics Blog, ethicsblog.crb.uu.se, June, 2016) "'Balanced Ethics Review: A Guide for Institutional Review Board Members' is a remarkable mini-handbook for IRB members. ... it offers principles and policies to guide IRB members in their deliberations, some of which are not universally supported. The book is thus very useful not just for beginners but also for experienced IRB professionals seeking a conceptual structure for their work." (Norman M. Goldfarb, Journal of Clinical Research Best Practices, Vol. 12 (5), May, 2016) "Whitney has done serious research work, and has included relevant practical experience. ... there is no doubt it is good IRB manual and 'must read' balanced review book." (Iva Rincic, JAHR - European Journal of Bioethics, Vol. 7 (13), 2016)