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Contents

Ethical Review of Studies and Informed Consent

Chapter:
Ethical and Legal Considerations
Author(s):

Annette Flanagin

To protect the safety and dignity of individuals who participate in research, academic institutions and grant agencies require that any study involving human participants be reviewed and approved by an institutional review board (IRB) or independent ethics review committee. (Note: When referring to individuals who participate in studies, the word participant is preferred to subject [see , Correct and Preferred Usage, Correct and Preferred Usage of Common Words and Phrases]. However, a number of guidelines and regulations cited herein refer to human “subjects.”)The US National Institutes of Health (NIH) defines research as “any systematic investigation designed to develop or contribute

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