Customer Reviews

Evaluating the Science and Ethics of Research on Humans: A Guide for IRB Members

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This book focuses on two sets of issues that each citizen needs to better understand about the science and ethics of research on humans: (1) what scientific research is and (2) what the protection of humans in research is all about. This book takes the reader over the full span of a reseach study involving humans as study participants. It starts at the very inception of the idea that a scientific research question is deemed significant enough that it needs to be asked by a research study conducted on humans. It illuminates for the reader each step in the development and presentation of the specific research idea to an institutional review board for further examination and consideration of approval. It then takes the reader through the conduct of research over time, at all times identifying specifics about what needs to be watched for at each stage of a research study's completion to protect humans. It then takes the reader to a time "long after" study completion when new risks in certain studies are still being identified and asks the question why these new risks were not identified at an earlier time and why these risks were not considered at the time the research study was first conceived, developed, reviewed, and approved.

This book is needed today for the optimal protection of humans in research. The approaches used in the book are readily accesible to a broad audience and are clearly translated into language non-scientists can understand.

Ideal book for IRB members, principal investigators, and patients considering volunteering for a clinical trial!