Ethical Considerations When Preparing a Clinical Research Protocol

Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USA Eric Singer works at the Rutgers Cancer Institute of New Jersey, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA National Institutes of Health, Bethesda, MD, USA

"It has been over 10 years since the initial edition of this text. This second edition serves as a more updated, comprehensive, cursory reference toward the ethical considerations necessary for developing and implementing clinical research studies. The publication's most important message is delivered in section A.2.3., yet, it is a thread throughout the book: knowing the basic ethical principles as well as regulations relevant to clinical research are not enough; rather, it takes mentoring, discussing, and resolving constructs and concerns through a team approach, which may be raised and delivered by a clinical research protocol. My criticism of the book is that there is an unsettling lack of attention to the clinical research ethical requirement of "respect for enrolled subjects" as originally published by Emanuel et al. in 2000. The application of this principle is to be realized in the study monitoring processes that maximize benefit and minimize risk; those processes being commensurate with the level of risk offered by the study design, intervention, and/or population and environment in which the protocol will be conducted, as well as the personnel by which it will be conducted. Of particular note is that this monitoring may (or may not) call for independent monitoring outside of the study team as well as Institutional Review Board (IRB). The material of the text appears to be limited to the concept of a Data and Safety Monitoring Board, which is only briefly mentioned and, as only a recent phenomenon, not so! While there are other publications that more fully address the ethical principle of "respect for enrolled subjects," it would be beneficial for this book to expound on this ethical principle and how it can be achieved during study conduct, as the book presents other ethical principle that are primarily applied during protocol development and initiation." --Doody Review of the previous edition:"This book will be a very useful text and reference source for students and trainees at all levels, as well as for seasoned investigators and RERB members. The continuing proliferation of formal, degree-granting masters and doctoral training programs in clinical investigation at academic centers across the country underscores the need for a book like this. These programs, and the growing acceptance and recognition of professional certification programs for clinical research professionals, are indicators that the expectations we place on investigators are greater than they were just a few years ago. Recognition that good science and good ethics are inextricably bound together in clinical research is today’s reality, and this book gives real insight into why and how." --JAMA, February 2006

• 1. What You Need To Know About Research Ethics Before Deciding on What You Want To Study 2. Designing a Clinical Research Study 3. Writing Consent and Assent Documents 4. Getting the Protocol Approved 5. Conducting the Study; Special Populations 6. Ethical Considerations in Genetics Research 7. Ethical Considerations in Use of Tissue for Laboratory Investigations 8. Ethical Considerations in Use of Stored Tissue9. Confidentiality Issues 10. Research in Emergency Medicine 11. Reporting of Adverse Events 12. FDA 13. Radiation Safety Issues 14. Participation of Subjects in Multi-Site Trials15. Participation of Subjects in Multiple Studies16. Conduct of Pharmaceutical Industry Research 17. Case Histories, Learning from Experience