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.
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