Evaluating the Science and Ethics of Research on Humans

A Guide for Irb Members
Erscheinungsjahr 2007
ISBN: 978-0-8018-8501-3
Verlag: Johns Hopkins University Press

Buch, Englisch, 272 Seiten, Format (B × H): 156 mm x 239 mm, Gewicht: 449 g

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.

Autoren/Hrsg.

Mazur, Dennis J

Fachgebiete

• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Biomedizin, Medizinische Forschung, Klinische Studien
• Interdisziplinäres Wissenschaften Wissenschaften: Forschung und Information Forschungsmethodik, Wissenschaftliche Ausstattung
• Medizin | Veterinärmedizin Medizin | Public Health | Pharmazie | Zahnmedizin Medizin, Gesundheitswesen Medizinische Ethik

Inhaltsverzeichnis

Preface
Introduction: What Can the New IRB Member Expect?
Part I: The IRB, Its Work, and Its Challenges
1. What Is an IRB, and What Does It Do?
2. Basic Terms and Concepts Used in IRB Work
3. What Is Risk?
Part II: The Scientific Protocol and the Informed Consent Form
4. Prescreening of Proposals
5. The Scientific Protocol
6. The Informed Consent Form
7. Recruitment, Selection, and Compensation of Study Participants
8. Research involving Questionnaires and Surveys
9. Protection of Participants' Privacy in Research Dataand Specimens
Part III: The Continuing Work of the IRB
10. The Ethical Issues of Informed Consent
11. Continuing Review, Communication, and Feedback
12. Where Are IRBs Making Mistakes, and How Can We Minimize Mistakes?
13. Strategies for Managing the IRB Workload and Supporting IRB Decision Making
14. Decision-Making Capacity and Accountability in Research
Summary: The IRB's Key Role
Appendix 1: A Check List for Reviewing a Scientific Protocol
Appendix 2: A Check List for Reviewing an Informed Consent Form
Notes
Website References for Cited Documents
Index

Über Autor(innen)

Mazur, Dennis J
Dennis J. Mazur, M.D., Ph.D., is a professor of medicine and senior scholar at the Center for Ethics in Health Care, Oregon Health and Science University. Dr. Mazur chaired the institutional review board in the Department of Veterans Affairs Medical Center, Portland, Oregon, for over fifteen years, and Dr. Mazur helped develop and continues to chair the VISN 20 northwest regional multi-site institutional review board.