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Cover of Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report

Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report

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Washington (DC): National Academies Press (US); .

The FDA requested that the IOM examine the ethical and informed consent issues that should be considered when conducting clinical trials to evaluate drug safety. This report outlines when and how the FDA should conduct clinical trials to protect the public's health and the health of trial participants.

This study was supported by Contract HHSF223200810020I between the National Academy of Sciences and the Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

Suggested citation:

IOM (Institute of Medicine). 2010. Ethical Issues in Studying the Safety of Approved Drugs: A Letter Report. Washington, DC: The National Academies Press.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

Copyright 2010 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK209932PMID: 24983038DOI: 10.17226/12948

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