Biomedical research on humans is an important part of medical progress. But, when health and lives are at risk, safety and ethical practices need to be the top priority. The need for the committees that regulate and oversee such research -- institutional review boards, or IRBs -- is growing. Evaluating the Science and Ethics of Research on Humans is a guide for new and veteran members of IRBs that will help them better understand the issues involved and the tasks they will be required to perform. The most important purpose of an IRB is to protect the human participants in research. For three major research areas -- drugs, medical devices, and genetic information -- Dennis J. Mazur shares the methods he has found useful in protecting human participants through the systematic review of scientific protocols and informed consent forms and through adherence to the federal regulations that apply. New members will gain understanding of how proposed research projects are to be reviewed from both scientific and ethical dimensions, how and when to ask key questions of principal investigators, how to work with principal investigators and research teams to ensure the best protection of human participants, and why to schedule regularly spaced reviews of a project that may have adverse outcomes.Containing helpful summaries and checklists throughout and based on Mazur's thirty years of research experience, this accessible and informative guide will give all IRB members the tools they need to protect human lives and facilitate the research process.
PrefaceIntroduction: What Can the New IRB Member Expect?Part I: The IRB, Its Work, and Its Challenges1. What Is an IRB, and What Does It Do?2. Basic Terms and Concepts Used in IRB Work3. What Is Risk?Part II: The Scientific Protocol and the Informed Consent Form4. Prescreening of Proposals5. The Scientific Protocol6. The Informed Consent Form7. Recruitment, Selection, and Compensation of Study Participants8. Research involving Questionnaires and Surveys9. Protection of Participants' Privacy in Research Dataand SpecimensPart III: The Continuing Work of the IRB10. The Ethical Issues of Informed Consent11. Continuing Review, Communication, and Feedback12. Where Are IRBs Making Mistakes, and How Can We Minimize Mistakes?13. Strategies for Managing the IRB Workload and Supporting IRB Decision Making14. Decision-Making Capacity and Accountability in ResearchSummary: The IRB's Key RoleAppendix 1: A Check List for Reviewing a Scientific ProtocolAppendix 2: A Check List for Reviewing an Informed Consent FormNotesWebsite References for Cited DocumentsIndex
""Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members goes beyond the basics to provide an excellent resource for any IRB member serious about his or her responsibilties. Along with a readable and compact presentation of the information one would expect in a handbook for IRB members, the book addresses [many] subtleties...""
